2,635 Clinical Data Management jobs in the United States

Sr. Manager, Clinical Data Management

92698 Aliso Viejo, California Terumo Neuro

Posted 2 days ago

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Job Description

**12521BR**
**Title:**
Sr. Manager, Clinical Data Management
**Job Description:**
The Senior Manager, CDM oversees clinical data management activities across multiple studies from study start-up through study closure. This includes prioritizing projects in support of corporate goals and objectives and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties:
+ Develop and implement SOPs to ensure GCP/ICH compliance for data management, database operations, clinical report writing, case report forms, and associated procedures.
+ Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
+ Assist in budget planning and resource allocation as it relates to data management.
+ Develop and implement clinical trial database, including CRF development and all aspects of data management.
+ Manage, plan, and coordinate the activities of the data management team members.
+ Oversee data management vendors, ensuring requirements are met and consistent.
+ Audit data management vendors, as appropriate.
+ Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines.
+ Review and approve CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.
+ Review study documents, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
+ Participate in the development of EDC User Acceptance Test (UAT) and custom report specifications as needed.
+ Plan, manage and coordinate all data management activities to ensure consistency of clinical data process across studies.
+ Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Contribute to activities supporting audits & inspection readiness and regulatory inspections.
+ Performs additional responsibilities as assigned.
Salary Range
$140,500-$84,500 Financial compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand
**Auto req ID:**
12521BR
**Location MV:**
Aliso Viejo, California, USA
**Department Name:**
807-CONFIDENCE
**Qualifications:**
1. Bachelor's degree in Science, Computer Science, or equivalent combination of training and experience.
2. Minimum seven (7) years of clinical data- management experience in the pharmaceutical, device or CRO setting.
3. Previous supervisory experience.
4. Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives.
5. Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans, Data Transfer Plans.
**Desired Qualifications**
1. Well organized, analytical and self-confident person.
2. Solid experience in developing, implementing, and validating data management systems and Electronic Data Capture (EDC).
3. Strong communication skills and interpersonal skills, ability to coach and mentor.
4. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.
5. Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
6. Able to work independently, as well as part of a team.
EEO
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.
Fair Chance Ordinance
If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.
**External-Facing Title:**
Sr. Manager, Clinical Data Management
**Posting Country:**
US - United States
**Salary Range:**
140,500- 184,500 Financial compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.
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Senior Manager, Clinical Data Management

08544 Princeton, New Jersey Bristol Myers Squibb

Posted today

Job Viewed

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Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Functional Area Description**
Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock.
**Position Summary**
The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management
This is an office-based in BMS New Jersey locations.
**Position Responsibilities**
Responsibilities will include, but are not limited to:
**Project Management and Leadership**
+ Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
+ Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
+ Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
+ Provides strong quality and project oversight over third party vendor responsible for data management deliverables
+ Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
+ Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
+ Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
+ Represents DM on cross-functional project teams & submission Teams
+ Lead or support the Health Authority inspections and audits
+ Provides coaching and quality oversight of junior Data Management Leads
**FSP/CRO/Vendor Oversight**
+ May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
**Continuous improvement initiatives**
+ Provides the relevant support and input to continuous improvement activities within clinical data management
+ Provides support for CAPA implementation as required
**Degree/ Experience Requirements**
+ Bachelor's Degree required with an advanced degree preferred
+ At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
**Key Competency Requirements**
+ Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
+ Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
+ Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
+ Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
+ Excellent oral and written communication skills. Communicate effectively with senior management and cross-functional teams
+ Knowledge of submission requirements, (e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA))
**Travel Required:** 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
Madison - Giralda - NJ - US: $143,590 - $73,998
Princeton - NJ - US: 143,590 - 173,998
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :05:55.833 UTC
**Location:** Madison-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Senior Manager, Clinical Data Management

07940 Madison, New Jersey Bristol Myers Squibb

Posted today

Job Viewed

Tap Again To Close

Job Description

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Functional Area Description**
Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock.
**Position Summary**
The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management
This is an office-based in BMS New Jersey locations.
**Position Responsibilities**
Responsibilities will include, but are not limited to:
**Project Management and Leadership**
+ Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
+ Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
+ Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
+ Provides strong quality and project oversight over third party vendor responsible for data management deliverables
+ Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
+ Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
+ Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
+ Represents DM on cross-functional project teams & submission Teams
+ Lead or support the Health Authority inspections and audits
+ Provides coaching and quality oversight of junior Data Management Leads
**FSP/CRO/Vendor Oversight**
+ May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
**Continuous improvement initiatives**
+ Provides the relevant support and input to continuous improvement activities within clinical data management
+ Provides support for CAPA implementation as required
**Degree/ Experience Requirements**
+ Bachelor's Degree required with an advanced degree preferred
+ At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
**Key Competency Requirements**
+ Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
+ Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
+ Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
+ Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
+ Excellent oral and written communication skills. Communicate effectively with senior management and cross-functional teams
+ Knowledge of submission requirements, (e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA))
**Travel Required:** 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
Madison - Giralda - NJ - US: $143,590 - $73,998
Princeton - NJ - US: 143,590 - 173,998
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :05:55.833 UTC
**Location:** Madison-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Director, Clinical Data Management Medical Coding

02112 Boston, Massachusetts Takeda Pharmaceutical

Posted 1 day ago

Job Viewed

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Job Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Data Management Medical Codingbased remotely reporting to the VP, Clinical Data Operations & Standards.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.Here, you will be a necessary contributor to our inspiring, bold mission.GOALS: Responsible for designing and implementing the medical coding strategy for Takeda clinical trial data, including staffing model and vendor partnership strategy. They will ensure delivery of timely and quality coding deliverables for clinical trials and programs in order to meet industry and regulatory requirements for clinical trial coding.Manage and oversee Takeda staff, strategic partners and vendors who conduct coding activities. They are responsible for oversight conduct of Data Management Coding activities at the program, group of programs and/or portfolio level - as performed within Takeda or by strategic partners, CROs or other 3rd party vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.Provide and enable solutions for complex problem solving that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder groups on the medical coding strategy, implementation, and quality oversight.Provide coding expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.ACCOUNTABILITIES:Lead the design and implementation of Takeda’s long-term clinical trial data coding strategy, including staffing model, vendor partnership, technology selection and adoption as applicable.Ensure achievement of clinical trial coding deliverables and activities that support Takeda regulatory commitments including submission of safety data.Liaise with cross functional and technology senior leaders to ensure alignment on medical coding strategy.Serve as a medical coding subject matter expert.Partner with stakeholders to optimize technology that supports efficient dictionary management processes and oversight of vendor coding quality. In collaboration with Takeda’s Global Coding Committee develop, implement, and evaluate Takeda coding conventions to ensure consistency and to optimize integration capabilities within and across therapeutic areas and programs. Develop and maintain strong relationships with vendors who perform clinical trial coding, ensuring high quality deliverables, consistent application of coding conventions, implementation, and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary. Develop and maintain coding and dictionary management process for Takeda in collaboration with key stakeholders.Ensure review of program and study level clinical trial adverse events, serious adverse events (SAE), concomitant medications and other relevant coded data performed by vendors for quality and consistency.Develop and manage coding staff to support Takeda’s medical coding strategy.Participate in and provide strategic input to cross-functional initiatives such as cross-functional data review, study operational initiatives, and technology initiatives.EDUCATION AND EXPERIENCE: MS/BS degree (RN or RPH preferred) in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience10 or more years of clinical data management coding experience in the pharmaceutical or biotechnology industry. 7 or more years experience of expert knowledge managing vendor relationships and alliance partnerships.5 or more years of line management experience or equivalent.Proven track record of strong project management skills and experience managing data management coding activities for large drug development programs.Expert knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management and medical coding; clinical experience in the one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, and/or vaccine.Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management). Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.Strong understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.Strong knowledge of one or more coding and clinical trial data management systems (Oracle Clinical, Oracle TMS, Medidata RAVE, InForm, etc.). Experience overseeing vendors performing clinical trial medical coding. Experience developing and maintaining coding processes and conventions.Experience liaising with senior-level stakeholders. Experience with budget planning. Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Massachusetts - VirtualU.S. Base Salary Range:$174,500.00 - $274,230.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #LI-Remote
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Director, Clinical Data Management Medical Coding

02298 Boston, Massachusetts Takeda Pharmaceutical Company Ltd

Posted today

Job Viewed

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Job Description

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Data Management Medical Coding based remotely reporting to the VP, Clinical Data Operations & Standards.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

  • Responsible for designing and implementing the medical coding strategy for Takeda clinical trial data, including staffing model and vendor partnership strategy. They will ensure delivery of timely and quality coding deliverables for clinical trials and programs in order to meet industry and regulatory requirements for clinical trial coding.
  • Manage and oversee Takeda staff, strategic partners and vendors who conduct coding activities. They are responsible for oversight conduct of Data Management Coding activities at the program, group of programs and/or portfolio level - as performed within Takeda or by strategic partners, CROs or other 3rd party vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.
  • Provide and enable solutions for complex problem solving that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder groups on the medical coding strategy, implementation, and quality oversight.
  • Provide coding expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.

ACCOUNTABILITIES:

  • Lead the design and implementation of Takedas long-term clinical trial data coding strategy, including staffing model, vendor partnership, technology selection and adoption as applicable.

  • Ensure achievement of clinical trial coding deliverables and activities that support Takeda regulatory commitments including submission of safety data.

  • Liaise with cross functional and technology senior leaders to ensure alignment on medical coding strategy.

  • Serve as a medical coding subject matter expert.

  • Partner with stakeholders to optimize technology that supports efficient dictionary management processes and oversight of vendor coding quality.

  • In collaboration with Takedas Global Coding Committee develop, implement, and evaluate Takeda coding conventions to ensure consistency and to optimize integration capabilities within and across therapeutic areas and programs.

  • Develop and maintain strong relationships with vendors who perform clinical trial coding, ensuring high quality deliverables, consistent application of coding conventions, implementation, and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary.

  • Develop and maintain coding and dictionary management process for Takeda in collaboration with key stakeholders.

  • Ensure review of program and study level clinical trial adverse events, serious adverse events (SAE), concomitant medications and other relevant coded data performed by vendors for quality and consistency.

  • Develop and manage coding staff to support Takedas medical coding strategy.

  • Participate in and provide strategic input to cross-functional initiatives such as cross-functional data review, study operational initiatives, and technology initiatives.

EDUCATION AND EXPERIENCE:

  • MS/BS degree (RN or RPH preferred) in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience

  • 10 or more years of clinical data management coding experience in the pharmaceutical or biotechnology industry.

  • 7 or more years experience of expert knowledge managing vendor relationships and alliance partnerships.

  • 5 or more years of line management experience or equivalent.

  • Proven track record of strong project management skills and experience managing data management coding activities for large drug development programs.

  • Expert knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management and medical coding; clinical experience in the one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, and/or vaccine.

  • Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management).

  • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

  • Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

  • Strong understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

  • Strong knowledge of one or more coding and clinical trial data management systems (Oracle Clinical, Oracle TMS, Medidata RAVE, InForm, etc.).

  • Experience overseeing vendors performing clinical trial medical coding.

  • Experience developing and maintaining coding processes and conventions.

  • Experience liaising with senior-level stakeholders.

  • Experience with budget planning.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time

Job Exempt

Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

#LI-Remote

View Now

Director, Clinical Data Management Medical Coding

02133 Boston, Kentucky Takeda Pharmaceuticals

Posted 1 day ago

Job Viewed

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Job Description

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Data Management Medical Coding based remotely reporting to the VP, Clinical Data Operations & Standards.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
**GOALS:**
**Responsible for designing and implementing the medical coding strategy for Takeda clinical trial data, including staffing model and vendor partnership strategy. They will ensure delivery of timely and quality coding deliverables for clinical trials and programs in order to meet industry and regulatory requirements for clinical trial coding.**
**Manage and oversee Takeda staff, strategic partners and vendors who conduct coding activities. They are responsible for oversight conduct of Data Management Coding activities at the program, group of programs and/or portfolio level - as performed within Takeda or by strategic partners, CROs or other 3rd party vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.**
**Provide and enable solutions for complex problem solving that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder groups on the medical coding strategy, implementation, and quality oversight.**
**Provide coding expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.**
**ACCOUNTABILITIES:**
+ Lead the design and implementation of Takeda's long-term clinical trial data coding strategy, including staffing model, vendor partnership, technology selection and adoption as applicable.
+ Ensure achievement of clinical trial coding deliverables and activities that support Takeda regulatory commitments including submission of safety data.
+ Liaise with cross functional and technology senior leaders to ensure alignment on medical coding strategy.
+ Serve as a medical coding subject matter expert.
+ Partner with stakeholders to optimize technology that supports efficient dictionary management processes and oversight of vendor coding quality.
+ In collaboration with Takeda's Global Coding Committee develop, implement, and evaluate Takeda coding conventions to ensure consistency and to optimize integration capabilities within and across therapeutic areas and programs.
+ Develop and maintain strong relationships with vendors who perform clinical trial coding, ensuring high quality deliverables, consistent application of coding conventions, implementation, and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary.
+ Develop and maintain coding and dictionary management process for Takeda in collaboration with key stakeholders.
+ Ensure review of program and study level clinical trial adverse events, serious adverse events (SAE), concomitant medications and other relevant coded data performed by vendors for quality and consistency.
+ Develop and manage coding staff to support Takeda's medical coding strategy.
+ Participate in and provide strategic input to cross-functional initiatives such as cross-functional data review, study operational initiatives, and technology initiatives.
**EDUCATION AND EXPERIENCE:**
+ MS/BS degree (RN or RPH preferred) in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience
+ 10 or more years of clinical data management coding experience in the pharmaceutical or biotechnology industry.
+ 7 or more years experience of expert knowledge managing vendor relationships and alliance partnerships.
+ 5 or more years of line management experience or equivalent.
+ Proven track record of strong project management skills and experience managing data management coding activities for large drug development programs.
+ Expert knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management and medical coding; clinical experience in the one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, and/or vaccine.
+ Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management).
+ Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
+ Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
+ Strong understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
+ Strong knowledge of one or more coding and clinical trial data management systems (Oracle Clinical, Oracle TMS, Medidata RAVE, InForm, etc.).
+ Experience overseeing vendors performing clinical trial medical coding.
+ Experience developing and maintaining coding processes and conventions.
+ Experience liaising with senior-level stakeholders.
+ Experience with budget planning.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Massachusetts - Virtual
**U.S. Base Salary Range:**
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Massachusetts - Virtual
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#LI-Remote
View Now

Associate Director Of Clinical Data Management

19428 Conshohocken, Pennsylvania Actalent

Posted 1 day ago

Job Viewed

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Job Description

Job Title: Associate Director of Clinical Data Management
Job Description
As an Associate Director of Clinical Data Management, you will lead and oversee a team within Clinical Data Management, ensuring the successful execution of data management deliverables for large, complex clinical trials or programs involving multiple trials. You will be responsible for developing data management strategies, managing vendors, reviewing contracts, and ensuring compliance with SOPs and regulatory guidelines. You will also act as the main point of communication for internal discussions, escalations, and stakeholder management concerning data management topics.
Responsibilities
+ Mentor and guide the Clinical Data Management (CDM) team, aligning with strategic goals.
+ Develop and implement strategies for maintaining high-quality data from database build through cleaning and review.
+ Represent CDM in program and study meetings, influencing resourcing decisions.
+ Serve as the senior CDM representative on multi-disciplinary teams, ensuring alignment on CDM activities.
+ Lead initiatives to streamline operations and sponsor department-level improvements.
+ Manage key data management activities using project management methodologies.
+ Manage relationships and alignment with cross-functional stakeholders and leadership.
+ Oversee data management vendors, ensuring that their delivery meets expectations.
Essential Skills
+ Proficiency in data management and EDC systems such as Medidata RAVE.
+ Strong vendor management skills.
+ Experience with database lock processes.
+ Knowledge of oncology data and clinical trial processes.
+ Expertise in CRF design and clinical data management.
+ Bachelor's or Master's degree in Life Sciences, Statistics, Informatics, Computer Sciences, or equivalent experience.
+ At least 12 years of directly relevant work experience.
+ Experience as a Clinical Data Manager in pharma/biotech or CRO.
+ Demonstrated leadership in DM technical responsibilities and systems.
+ Skilled in negotiating solutions with cross-functional teams.
+ Strong communication skills, especially with senior stakeholders.
+ Experience managing CROs and DM-related vendors.
+ Understanding of regulatory guidelines and industry standards such as ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries.
+ Knowledge of Phase 1-4 clinical studies and core DM tasks.
+ Excellent project management and multitasking skills.
+ Attention to detail and ability to work independently or in teams, including with external partners/vendors.
Additional Skills & Qualifications
+ Oncology and Phase III/Pivotal study experience preferred.
+ Strong technical skills and experience with various DM systems.
Work Environment
The role requires working on-site in Conshohocken, PA, three days a week up to five.
Job Type & Location
This is a 12-month renewable contract position based out of Conshohocken, Pennsylvania.
Pay and Benefits
The pay range for this position is $80.00 - $96.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Conshohocken,PA.
Application Deadline
This position is anticipated to close on Oct 17, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now
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Associate Director Of Clinical Data Management

19428 Conshohocken, Pennsylvania Actalent

Posted 3 days ago

Job Viewed

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Job Description

Job Title: Associate Director of Clinical Data Management
Job Description
As an Associate Director of Clinical Data Management, you will lead and oversee a team within Clinical Data Management, ensuring the successful execution of data management deliverables for large, complex clinical trials or programs involving multiple trials. You will be responsible for developing data management strategies, managing vendors, reviewing contracts, and ensuring compliance with SOPs and regulatory guidelines. You will also act as the main point of communication for internal discussions, escalations, and stakeholder management concerning data management topics.
Responsibilities
+ Mentor and guide the Clinical Data Management (CDM) team, aligning with strategic goals.
+ Develop and implement strategies for maintaining high-quality data from database build through cleaning and review.
+ Represent CDM in program and study meetings, influencing resourcing decisions.
+ Serve as the senior CDM representative on multi-disciplinary teams, ensuring alignment on CDM activities.
+ Lead initiatives to streamline operations and sponsor department-level improvements.
+ Manage key data management activities using project management methodologies.
+ Manage relationships and alignment with cross-functional stakeholders and leadership.
+ Oversee data management vendors, ensuring that their delivery meets expectations.
Essential Skills
+ Proficiency in data management and EDC systems such as Medidata RAVE.
+ Strong vendor management skills.
+ Experience with database lock processes.
+ Knowledge of oncology data and clinical trial processes.
+ Expertise in CRF design and clinical data management.
+ Bachelor's or Master's degree in Life Sciences, Statistics, Informatics, Computer Sciences, or equivalent experience.
+ At least 12 years of directly relevant work experience.
+ Experience as a Clinical Data Manager in pharma/biotech or CRO.
+ Demonstrated leadership in DM technical responsibilities and systems.
+ Skilled in negotiating solutions with cross-functional teams.
+ Strong communication skills, especially with senior stakeholders.
+ Experience managing CROs and DM-related vendors.
+ Understanding of regulatory guidelines and industry standards such as ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries.
+ Knowledge of Phase 1-4 clinical studies and core DM tasks.
+ Excellent project management and multitasking skills.
+ Attention to detail and ability to work independently or in teams, including with external partners/vendors.
Additional Skills & Qualifications
+ Oncology and Phase III/Pivotal study experience preferred.
+ Strong technical skills and experience with various DM systems.
Work Environment
The role requires working on-site in Conshohocken, PA, three days a week up to five.
Job Type & Location
This is a Contract position based out of Conshohocken, Pennsylvania.
Pay and Benefits
The pay range for this position is $80.00 - $96.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Conshohocken,PA.
Application Deadline
This position is anticipated to close on Oct 17, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now

Associate Director Of Clinical Data Management

19428 Conshohocken, Pennsylvania Actalent

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

Job Title: Associate Director of Clinical Data Management
Job Description
As an Associate Director of Clinical Data Management, you will lead and oversee a team within Clinical Data Management, ensuring the successful execution of data management deliverables for large, complex clinical trials or programs involving multiple trials. You will be responsible for developing data management strategies, managing vendors, reviewing contracts, and ensuring compliance with SOPs and regulatory guidelines. You will also act as the main point of communication for internal discussions, escalations, and stakeholder management concerning data management topics.
Responsibilities
+ Mentor and guide the Clinical Data Management (CDM) team, aligning with strategic goals.
+ Develop and implement strategies for maintaining high-quality data from database build through cleaning and review.
+ Represent CDM in program and study meetings, influencing resourcing decisions.
+ Serve as the senior CDM representative on multi-disciplinary teams, ensuring alignment on CDM activities.
+ Lead initiatives to streamline operations and sponsor department-level improvements.
+ Manage key data management activities using project management methodologies.
+ Manage relationships and alignment with cross-functional stakeholders and leadership.
+ Oversee data management vendors, ensuring that their delivery meets expectations.
Essential Skills
+ Proficiency in data management and EDC systems such as Medidata RAVE.
+ Strong vendor management skills.
+ Experience with database lock processes.
+ Knowledge of oncology data and clinical trial processes.
+ Expertise in CRF design and clinical data management.
+ Bachelor's or Master's degree in Life Sciences, Statistics, Informatics, Computer Sciences, or equivalent experience.
+ At least 12 years of directly relevant work experience.
+ Experience as a Clinical Data Manager in pharma/biotech or CRO.
+ Demonstrated leadership in DM technical responsibilities and systems.
+ Skilled in negotiating solutions with cross-functional teams.
+ Strong communication skills, especially with senior stakeholders.
+ Experience managing CROs and DM-related vendors.
+ Understanding of regulatory guidelines and industry standards such as ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries.
+ Knowledge of Phase 1-4 clinical studies and core DM tasks.
+ Excellent project management and multitasking skills.
+ Attention to detail and ability to work independently or in teams, including with external partners/vendors.
Additional Skills & Qualifications
+ Oncology and Phase III/Pivotal study experience preferred.
+ Strong technical skills and experience with various DM systems.
Work Environment
The role requires working on-site in Conshohocken, PA, three days a week up to five.
Job Type & Location
This is a Contract position based out of Conshohocken, Pennsylvania.
Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information.
Pay and Benefits
The pay range for this position is $80.00 - $96.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Conshohocken,PA.
Application Deadline
This position is anticipated to close on Oct 20, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now

Associate Director, External Clinical Data Management

07059 Warren, New Jersey Regeneron Pharmaceuticals

Posted 6 days ago

Job Viewed

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Job Description

The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron's procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strategic direction. Additionally, the AD works with senior leadership to define goals, staffing needs, and departmental structure.
**A typical day in the life as an Associate Director, External Data Services includes:**
+ Shape and implement the strategy for External Data Services.
+ Lead and manage a team of External Data Services Managers and Specialists.
+ Oversee the development and maintenance of all DTS documents, ensuring alignment with Regeneron standards, processes, and timelines.
+ Drive the External Data Vendor Oversight model, establishing effective communication, partnership-level processes, and portfolio-level transparency on DTS status and escalations.
+ Represent External Data Services in leadership forums and technology discussions.
+ Contribute to and execute the External Data Services technology strategy.
+ Provide expert-level guidance to CROs, stakeholders, and external vendors on External Data Services.
+ Identify process gaps and lead initiatives to improve processes.
+ Track milestones and deliverables, escalate issues, and communicate portfolio-level updates to stakeholders.
+ Lead or contribute to special projects requiring strategic input and expertise in External Data.
+ Serve as a subject matter expert (SME) for complex topics requiring leadership-level commitment.
+ Develop SOPs, Work Instructions, Guidance Manuals, and other DTS development tools.
+ Provide coaching, mentoring, and performance management for direct reports.
+ Manage resource allocation and planning for External Data Services.
**This Role Might Be for You If You:**
+ Have expert knowledge of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
+ Possess deep expertise in Data Management, External Data processes, and industry best practices.
+ Demonstrate advanced experience with extracting data in SAS, CSV, and XML formats.
+ Can address complex External Data challenges and recommend actionable solutions.
+ Have a proven ability to develop best practices and processes to achieve objectives.
+ Exhibit strong problem-solving, analytical, and project management skills.
+ Thrive in a matrix environment with virtual teams and can motivate others effectively.
+ Possess an excellent understanding of cross-functional activities and their intersections with External Data.
+ Manage multiple priorities with attention to detail and deliver results within tight timelines.
+ Communicate effectively through strong interpersonal, oral, and written skills.
+ Adapt quickly in a fast-paced, dynamic environment.
+ Are open to travel up to 20%.
**To be qualified for this role, you must meet the following requirements:**
+ A minimum of **10+ years of experience** in External Clinical Data Management, with expert knowledge of database structures in biotechnology, pharmaceutical, or health-related industries.
+ At least **4 years of people management experience** .
+ A **Bachelor's degree** in Science, Health, Computing, or a related field.
+ Hands-on experience with **Imaging Data** is required.
+ Advanced knowledge of **Biomarker data types** and/or Imaging Data for oncology and non-oncology studies is a plus.
+ Expert knowledge of database structures is preferred.
This role is ideal for a seasoned professional who thrives at the intersection of leadership, technical expertise, and strategic vision. If you're ready to make a significant impact in External Data Services, this position could be your next career milestone.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$154,800.00 - $252,800.00
View Now
 

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