3,844 Patient Data jobs in the United States

Patient Safety RN Clinical Data Analyst

32701 Altamonte Springs, Florida AdventHealth

Posted 2 days ago

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Job Description

**AdventHealth Corporate**
**All the benefits and perks you need for you and your family:**
Benefits from Day One
Career Development
Whole Person Wellbeing Resources
Mental Health Resources and Support
**Our promise to you:**
Joining AdventHealth is about being part of something bigger. Its about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better.
**Shift** : Monday- Friday
**Job Location** : Hybrid; Monday, Wednesday, Thursday onsite
**The role you will contribute:**
The primary role of the Data Analyst is to support thru analytics, problem solving and reporting. This position is responsible for ongoing analysis of health care information, obtained from a variety of sources including patient care, financial and demographic data. The position involves development and preparation of information products for AH facilities. This position requires the ability to analyze health care data from conceptualization through presentation of the data. It requires strong communication skills and a strong commitment to and affinity for delivering the highest level of customer service. The Data Analyst has the ability to work independently in gathering data and creating reports. The Data Analyst represents the department in the highest professional manner at all times.
**The value you will bring to the team:**
Support AH facilities and AH-IT to maintain timely regulatory measure collection and data transfer to CMS, Joint Commission and other agencies as needed.
Keep up to date with changes and additions to reporting requirements for regulatory measures
Facilitate and maintain regular user group support calls with AH facilities
Monitor and assist with improving the quality of data used by AH for reporting or sent to outside vendors or regulatory agencies
Performs data analysis in support of department and the AH facilities.
Maintain familiarity with clinical issues and events affecting department
Provide department and AH facilities with accurate and appropriate interpretation of data
Takes responsibility for assignment completion and presentation in accordance with set timelines, including consistent follow through and communication to supervisor of any outstanding issues
Displays proactive problem-solving independently and in collaboration with team members
Provide support and training on data collection or reporting tools as needed in order to serve the analytic needs of the AH facilities and department.
Responsible for exceptional customer service by promoting an image of a professional high quality organization through expertise and responsiveness.
Perform other duties as needed to support the ongoing operations
**The expertise and experiences you'll need to succeed:**
Bachelors in Information Systems, nursing or related health field or 5 years equivalent experience
Current experience working with healthcare data
Maintain State of Florida nursing license, if applicable
**Preferred Qualifications:**
Nursing Degree
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.
**Category:** Quality/Clinical Effectiveness
**Organization:** AdventHealth Corporate
**Schedule:** Full-time
**Shift:** 1 - Day
**Req ID:** 25025317
We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.
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Patient Data Specialist - Hemophilia & Thrombosis Tx Ctr Prg

96823 Honolulu, Hawaii Hawaii Pacific Health

Posted 1 day ago

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Kapi'olani Medical Center for Women & Children is Hawai'i's only maternity, newborn and pediatric specialty hospital. It is well recognized as Hawai'i's leader in the care of women, infants and children. With 253 beds, the not-for-profit hospital delivers 6,000 babies a year, and is also a medical teaching and research facility. Specialty services for patients throughout Hawai'i and the Pacific Region include intensive care for infants and children, 24-hour emergency pediatric and adult care, critical care air transport and high-risk perinatal care. Over 1,400 employees and more than 700 physicians provide specialty care at Kapi'olani. The hospital is home to the Kapi'olani Women's Center and the Women's Cancer Center, and offers numerous community programs and services, such as specialty pediatric clinics, the Kapi'olani Child Protection Center and the Sex Abuse Treatment Center.
The Kapi'olani Pediatric Resource Hospital Trauma Program coordinates a variety of clinical tools to provide multidisciplinary care to pediatric patients who have suffered medical trauma. Its staff plans, organizes, coordinates and evaluates all aspects of the trauma service, including delivery, performance, prevention, public education, training and continuing education, with the goal of building and strengthening a Pediatric Trauma Resource Hospital.
As the Patient Data Specialist, you will provide clerical support to the Hemophilia and Thrombosis Treatment Center Program. You will extract information from patient charts, update the data collection system and submit reports to various sources including research related websites. We are looking for someone with outstanding communication and organizational skills, and a commitment to creating a healthier Hawai'i.
**Location:** Kapiolani Medical Center for Women and Children
**Work Schedule:** Day - 8 Hours
**Work Type:** Full Time Regular
**FTE:** 1.000
**Bargaining Unit:** Non-Bargaining
**Exempt:** No
**Req ID** 29909
**Pay Range:** 23.65 - 26.28 USD per hour
**Category:** Administrative
**Minimum Qualifications:** High School Diploma or equivalent. Health Information Management (HIM) experience. Experience or training in medical terminology.
**Preferred Qualifications:** Associates degree in a Health related field. ICD-10 experience.
EOE/AA/Disabled/Vets
Hawai'i Pacific Health offers a comprehensive and competitive total rewards package that includes pay and benefits. Rate of pay for selected candidates will be determined by various factors including knowledge, skills, abilities, relevant experience and training, as well as internal peer equity.
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Director, Clinical Data Management

San Diego Country Estates, California BioPhase Solutions

Posted today

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Job Description

Job Description

Company Overview:We are a clinical-stage biopharmaceutical organization dedicated to discovering and developing innovative oral therapies for various medical indications with significant unmet needs. Our focus is on targeting biological pathways associated with specific clinical challenges to positively influence disease progression. Our pipeline features multiple programs across diverse therapeutic areas, including those related to pulmonary and fibrotic disorders.


Job Summary:The Director of Clinical Data Management will play a crucial role in supporting Clinical Operations and Biometrics by ensuring the completeness, accuracy, and consistency of clinical data. This position involves overseeing clinical data management activities performed by Contract Research Organizations (CROs), conducting detailed data reviews, and collaborating with cross-functional teams to meet project goals and timelines.


Key Responsibilities:

  • Participate in the selection process for CROs involved in data management activities, including proposal reviews and bid defenses.
  • Oversee CRO clinical data management activities for assigned clinical studies.
  • Manage user permissions and access for all clinical study-related platforms.
  • Review and provide feedback on data management and study documentation, including data management plans, study protocols, data transfer agreements, and validation specifications.
  • Ensure that case report forms are designed in accordance with study protocols and other relevant documentation.
  • Supervise the electronic data capture database build process, including the review of specifications and validation documents. Participate in user acceptance testing of various data systems during initial builds and subsequent updates.
  • Conduct thorough reviews of clinical trial data as required.
  • Represent the Clinical Data Management function in relevant internal and external meetings.
  • Ensure the timely delivery of project milestones and manage CRO performance accordingly.
  • Communicate the status of clinical trials, including milestones and deliverables, throughout the study duration.
  • Contribute to improvement initiatives within the Clinical Data Management department. Assist in the development and implementation of new technologies and tools. Create standard operating procedures and templates.
  • Supervise clinical data management activities and engage in direct negotiations with CROs regarding timelines and quality issues.
  • Support clinical data medical reviews.
  • Escalate unresolved data or compliance issues to relevant managers and work collaboratively with CRO data managers, partners, vendors, and internal teams to resolve them.
  • Assist the Quality Assurance department in conducting audits related to data management activities.


Education and Experience:

  • Bachelor’s degree from an accredited institution in a relevant field such as Life Sciences or Computer Science, or equivalent practical experience.
  • 10-15+ years of experience in Clinical Data Management within the biopharmaceutical or biotechnology industry, with a strong understanding of clinical drug development processes. Experience with NDA submissions is a plus.
  • In-depth knowledge of relevant data management systems and industry standards.
  • Detail-oriented, communicative, and accountable, with strong verbal and written communication skills.
  • Ability to work collaboratively in a team environment and demonstrate strong interpersonal skills.
  • Proven ability to be flexible and manage multiple tasks in a fast-paced, high-pressure setting.
  • Experience with CRO and vendor oversight is preferred.
  • Strong knowledge of clinical research and relevant regulatory requirements.
  • Proficiency in Microsoft Office Suite (Outlook, Word, Excel, etc.).


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Director, Clinical Data Management

San Diego Country Estates, California ADARx Pharmaceuticals Inc.

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Job Description

Job Description

We are seeking a highly motivated and qualified individual to join our Clinical Operations Department as a Director/Sr. Director, Clinical Data Management and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team.

The Director/Senior Director of Clinical Data Management, reporting to the VP, Clinical Operations, will provide oversight for data management activities across ADARX’s clinical studies. This role involves building and leading a DM department, defining strategy, and establishing an efficient DM operating model. This role will be accountable for creating and maintaining data processes and standards, ensuring the seamless integration and quality of data from electronic data capture (EDC) systems and other clinical trial data sources. In addition, this person will be responsible for building the standards for data collection, edit specifications, Data Management Plans, data systems validation and UAT, listing generation, as well as review of clinical data for completeness, accuracy, and compliance

Essential Responsibilities:

  • Oversee all Data Management activities for ADARX’s clinical trials, including oversight of vendors involved in clinical data management.
  • Lead and mentors CDM team members and contractors.
  • Review protocols and develop study plans to ensure that data collection and case report form (CRF) design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines).
  • Create or review standards and specifications for CRFs, database build and validation, edit checks, external system integration, or for other systems and processes related to data while enabling near-real time data access for ADARx clinical trials.
  • Collaborate with clinical development, biostatistics and clinical operations to develop short-term and long-term strategies to improve data management quality and efficiency.
  • Accountable for deliverables to meet company goals.
  • Prepare for audits and regulatory inspections by ensuring data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans.
  • Provide subject matter expertise to study team members during all phases of the project life cycle, electronic data capture, external data standardization, and prior, during, and after internal and external audits and inspections.
  • Manage the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements.
  • Generate metrics, reports, dashboards, and analytics to measure the performance of Clinical Data Management team across the portfolio.
  • Represent clinical data management as a Subject Matter Expert (SME) and build relationships with key vendors.
  • Effective interaction with senior level management across multiple functions.
  • Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
  • Maintain all appropriate corporate standards for facility safety.
  • Other duties as assigned.

Essential Physical Characteristics:

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol:

Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications :

  • BS/BA degree or higher in science, mathematics, computer science or a health-related field.
  • At least 10 years of clinical data management experience in a regulatory environment in the pharmaceutical or biotechnology industry.
  • Experience successfully leading a CDM team or group.
  • Extensive background collaborating with CROs, vendors, and internal study teams.
  • In-depth knowledge and experience with clinical systems.
  • Possesses a comprehensive understanding of regulatory guidelines and industry standards and their application to DM.
  • In-depth knowledge and experience with clinical systems.
  • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
  • Strong problem-solving skills and a proactive attitude towards exploring new approaches.
  • Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
  • Proficiency working with Microsoft Office Suite Products.

Preferred Qualifications:

  • Medrio experience is highly desirable.
  • A track-record of impacting drug discovery programs through driving projects to key decision points.

Required Key Attributes:

  • Demonstrates an appropriate balance of business and technical capabilities.
  • Capable of actively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
  • Must be able to work independently as well in cross-functional team settings with supervision as needed.
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
  • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.

Compensation:

  • This is a full-time position, Monday-Friday, occasional overtime.
  • Pay is commensurate with experience.
  • Equity-based compensation
  • Performance-based bonuses
  • 401(k) with Company Match
  • Medical, Dental, Vision
  • Flexible Spending Account
  • Life Insurance
  • Employee Assistance Program
  • Employee Discounts
  • Gym Membership
  • Paid Vacation
  • Paid Holidays
  • Paid Sick, Jury Duty, Bereavement

Work Authorization:

  • United States (Required)
  • Background Check
  • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

Company Overview:

We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

  • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
  • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
  • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
  • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
  • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

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Associate Director Clinical Data Management

94501 Alameda, California People With Chemistry

Posted 2 days ago

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Associate Clinical Data Management Director *Candidates need to work a hybrid model in Alameda, CA or King of Prussia, PA Meet has partnered with a leading biotechnology company focused on developing innovative therapies for cancer, advancing a robust pipeline of small molecules and biologics through strategic partnerships and cutting-edge research. They are looking for an Associate Clinical Data Management Director to join their team and serve as the lead study data manager for a large, complex trial or multiple, smaller studies. Key Responsibilities Work with different teams to plan and manage data tasks for clinical studies Make sure study documents are complete and data is accurate and ready on time Help design databases, check data quality, and support reports and submissions Guide team members, improve processes, and work with outside partners when needed Key Qualifications Bachelor's degree with 11+ years, Master's with 9+ years, or PhD with 5+ years of related experience; at least 7 years in clinical data management and 4 years in a leadership role Strong experience with Electronic Data Capture (EDC); familiarity with IVRS/IWRS preferred Solid knowledge of GCP, FDA regulations, and CDASH/CDISC standards Proven skills in project management, problem solving, and effective communication Please reach out to Martin Wenzel if you're interested in learning more: martin.wenzel@

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Associate Director, Clinical Data Management

92189 San Diego Country Estates, California Initial Therapeutics, Inc.

Posted 5 days ago

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Job Title:

Associate Director, Clinical Data Management

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA: Full time

Exempt

Department:

Clinical Operations

ID:

7525-Q224-21

Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving peoples lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.

The Opportunity

Reporting to the Head of Clinical Data Management, the Associate Director, Clinical Data Management will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations, statistical programming and biostatistics. The Associate Director, Data Management will ensure the clinical database's accuracy, consistency, completeness, and high quality. The role will work closely with cross-functional teams on the clinical development program, health authority submissions, presentations, and publications across internal and external stakeholders.

What You Will Contribute

  • Lead clinical data management oversight of outsourced clinical trials for Avidity clinical trials, including project management, vendor management, coordination of internal reviews, and approval of day-to-day data management deliverables
  • Assist Head of DM with setting up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts, and liaising with study management CRO to ensure site training and timely initiation
  • Provide direction and guidance to team members, including vendors, to achieve/meet corporate goals and milestones
  • Oversee database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standard and regulatory authority requirements
  • Responsible for client acceptance testing
  • Oversee data management activities to maintain consistency across trials, including development and implementation of data collection/review tools, data management documents, data flow metrics, and driving data snapshot/closeout activities
  • Proactively identify risks and execute risk mitigation strategies; Maintain timely communication with both management and cross-functional teams
  • Oversee CRO/Vendor activities to ensure GCP compliance, Avidity quality expectations are met, and timelines are adhered to
  • Contribute to process development with focus on efficient, streamlined procedures
  • Contribute to program deliverable timeline creation and project re-forecasting
  • Support data management activities for regulatory submissions
  • Performs additional duties as assigned

What We Seek

  • BS degree in life science or related field with minimum of 6+ years of CDM experience in CRO, biotech or pharmaceutical industry
  • A minimum of 2+ years in biotech/pharma organizations and 6+ years' hands-on data management experience as a DM study lead
  • Experience leading clinical studies from study start up to database lock and managing multiple programs, and/or multiple studies within a program
  • Strong vendor management and oversight experience, including oversight of CRO partners, eCOA, central laboratory, specialty lab and central readers
  • Experience with inspection readiness activities and participation in mock/actual inspections
  • Understanding of principles of clinical research, ICH GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and related regulatory requirements
  • Expertise with CDISC standards, including CDASH and SDTM; Experience with resolution of Pinnacle21 output
  • Proficiency with Medidata Rave EDC and other EDC platforms. Working knowledge of SAS or SQL preferred
  • Proficient in Microsoft Word, PowerPoint, MS Project, Outlook, and SharePoint
  • Experience in neuromuscular diseases or rare diseases preferred
  • Experience supporting regulatory submissions and inspection readiness/inspection experience
  • Ability to work well in a team environment both as a leader and a contributor
  • Excellent communication skills (written and oral) across all organizational levels
  • Collaborative, respectful, agile and transparent work style

What We Will Provide To You

? The base salary range for this role is $180,000-$199,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.

? Avidity offers competitive compensation and benefits, which include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.

? A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

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#J-18808-Ljbffr
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Associate Director, Clinical Data Management

08543 Princeton, New Jersey Kyowa Kirin North America

Posted 7 days ago

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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.Summary:Responsible for managing and overseeing all aspects of data management (DM) for assigned projects, including managing staff, selecting and overseeing DM vendors, supervising tasks performed by vendors, assuring data quality, interfacing with in-house staff in establishing and maintaining global data standards and department procedures.Essential Functions: Strong understanding of Risk Based Quality Management. High sensitivity to industry trends and the ability to leverage them in business Accountable for all aspects of data management tasks from vendor selection to new drug application. Conducting risk assessments related to data and designing data quality by mitigating risks. Oversee all aspects of data management tasks performed by vendor, which include but not limited to: Review CRF, database and dataset structure, Data Management Plan, Data Review Guidelines and edit specifications; Assure dictionary versions are correct; Request specific project tracking reports; Qualify vendor personnel; Review queries; Oversee change order activities; Perform internal activities associated with database lock at vendor (e.g. SAE reconciliation, dictionary term reconciliation, external vendor's data reconciliation and document collection). Collaborating with an external vendor to create a Data Transfer Agreement. Interface with internal and external staff: Participate on Project Teams; Review protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor(s) to review CRF coding for logic, consistency and medical appropriateness. Assure all clinical data is properly collected, cleaned and formatted, to assure data quality and data integrity for proper analysis and interpretation required for inclusion into reports and regulatory submissions. Work closely with DM vendors to ensure timelines are met and communicate to Project Management as appropriate in order to achieve KPIs. Archival of end-of-study documents as appropriate. Responsible for budget planning for DM-related tasks, department budget planning, and budget performance tracking. Supervise DM staff and manage DM resources Support sub-function head of data management in hiring data managers Negotiate with partner companies to obtain trial data. If there are gaps, develop alternatives to complete the submission materials. Participate as a subject matter expert in Regulatory Submissions and Regulatory Audits. Meet and discuss with Japanese HQ regularly, regarding global Data Management procedures, process and standards. Staying updated on industry trends, proposing new Data Management strategies, and executing them independently.Requirements:EducationBachelor's degree in science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experienceExperience Minimum 10 years' Clinical DM experience. Minimum 5 years' pharmaceutical company experience. Minimum 2 years' people management experience Multi Regional Clinical Trial experiences Experience in hematological cancers or bone/mineral studies is highly desirable Subject Matter Expert (SME) in FDA or EMA Inspections is highly desirable.Technical Skills Strong understanding of regulatory guidelines (and the related issues) (e.g. ICH/GCP) and the connection to DM deliverables (e.g. data quality and data integrity). Strong understanding of Risk Based Quality Management. Good understanding of Medical coding (MedDRA and WHO Drug dictionaries) to check consistency codes and upgrade. Strong familiarity with CDISC (CDASH/SDTM). Good understanding of Computerized System Validation Proficient in systems and tools used in clinical trials (EDC, BI tools). Proficient in Microsoft tools (Excel, Word, PowerPoint, etc.). Basic knowledge of Decentralized Clinical Trials(DCT) and AI(Artificial Intelligence)Working Conditions:Normal office environment with prolonged sitting and extensive computer work. Work in the office required at least 2 days a weekThere are international calls/meetings once or twice a week.Requires up to 10% of domestic and international travelThe anticipated salary for this position will be $180,000 to $190,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes a Summer and Winter Shut-Down, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Life & Disability Insurance Concierge Service Pet Insurance Tuition Assistance Employee Referral AwardsThe compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactionsIt is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing Controller's data protection officer can be contacted at Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at & Staffing AgenciesKyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.#LI-TT1 #Hybrid #Princeton

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Associate Director, Clinical Data Management

94199 San Francisco, California Nurix, Inc.

Posted 16 days ago

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Associate Director, Clinical Data Management Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease. Position Nurix has a place for an extraordinary, highly motivated, self-starter and accomplished Associate Director of Clinical Data Management to become a part of the growing biometrics organization. Summary The Associate Director of Clinical Data Management (CDM) will be responsible for the delivery and integrity of clinical data across Nurix's multiple studies/programs. The role will also be supporting process development and improvement in building clinical data management infrastructure. He/She will ensure adherence to industry guidelines in all clinical data management activities for assigned studies, as well as assisting in the development and implementation of departmental policies, operational guidelines, and administrative structure. The successful candidate should have a successful track record in managing vendors and effectively leading study clinical data management activities with the anticipated growth in the product pipeline. He/She must also possess excellent communication skills work closely with medical study directors and clinical operations to provide and receive direction to ensure high quality and integrity in clinical data. Additional key representative responsibilities will include, but not necessarily be limited to, the following: Job Responsibilities: Lead and manage clinical data management duties and tasks for assigned clinical trial from study start up to study closeout Manage and provide oversight of vendors (including clinical data management CRO) that have been contracted to handle Nurix's clinical data and ensure the data are complete, accurate and delivered within the agreed upon timelines Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with training Work collaboratively with internal and external team members within the study to coordinate the planning and execution of clinical data management activities Create strategies for rapid study start and database lock to increase clinical data management productivity Lead the design of the eCRFs and ensure that they align with the clinical protocol(s) Ensure complete and accurate documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, TLFs, etc. that are generated for CSRs, DSURs, IBs, and other business needs Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards Help establishing CDM processes and contribute to the development of key clinical data management SOPs Provide technical support and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specifications Perform budget review and guidance for clinical data management CRO for assigned trial Qualifications Bachelor's degree in a scientific discipline or equivalent (computer science, mathematics, statistics, epidemiology, biology, psychology). A Master's degree in a related science field is preferred Minimum of 10 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Associate Director level Minimum of 12 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Director level Direct experience working with Medidata Rave design and implementation Proficient on regulatory requirements for clinical data management and the regulatory submission process Extensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor's capabilities and ensuring the desired high-quality deliverables Demonstrated ability to operate and lead assigned study in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise Able to adapt quickly to the changing needs of the organization Able to organize multiple work assignments and establish priorities Excellent verbal and written communications skills; able to communicate proactively and effectively Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ( ). Apply for this job * indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf How did you hear about this job? * Select. Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)? * Select. #J-18808-Ljbffr

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Associate Director, Clinical Data Management

02298 Boston, Massachusetts Blue Cross Blue Shield of Massachusetts

Posted 23 days ago

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Job Description

Ready to help us transform healthcare? Bring your true colors to blue.

What we need

The Associate Director of Clinical Data Management will be a key leader in executing BCBSMA’s data & analytics strategy of becoming a data driven organization. The successful candidate will be responsible for leading the clinical data management function, providing strategic direction, and ensuring the delivery of high-quality, trustable clinical data to support key initiatives around quality, risk adjustment, medicare stars, and interoperability. This is a key leadership role that requires strong technical expertise, excellent communication and project management skills, and the ability to work collaboratively with cross-functional teams.

Your Day to Day

  • Develop and execute a comprehensive clinical data strategy aligned with organizational goals.

  • Lead the clinical data management function, including planning, execution, and delivery of clinical data management activities.

  • Provide strategic direction and execute on payor & provider clinical data exchanges.

  • Stay informed about emerging trends in clinical data management and leverage knowledge to enhance data strategies.

  • Collaborate with cross-functional teams, including clinical operations, performance measurement, and risk adjustment, to execute on data procurement & usage strategies.

  • Develop and implement clinical data management standards, processes, and procedures to ensure compliance with regulatory requirements and company policies.

  • Ensure the accuracy, completeness, and integrity of clinical data, including data cleaning, data validation, and data analysis.

  • Support and resolve vendor data integration issues, such as data mapping, transformation, and normalization.

  • Collaborate with external vendors, providers, and partners to ensure the delivery of high-quality clinical data.

  • Lead implementation of technology solutions with close partnership with business areas, architecture, engineering, product teams.

  • Develop and maintain clinical data management metrics and reports to track performance and identify areas for improvement.

  • Develop and implement data standards (HL7, FHIR, CCDAs) with focus on interoperability to enable seamless data exchange between systems and partners.

We’re Looking for:

  • Deep knowledge of clinical data domain in context of healthcare providers (EHR, EMRs) and payors (Claims, Labs, ADTs, Quality measures).

  • Excellent understanding and leadership experience in clinical data integration, data exchanges within and outside organization, technology implementations, industry standard frameworks for data sharing.

  • Proven people management experience with managing mix of contractors and FTEs reporting members in the team.

  • Collaborates with peers, leaders, and business stakeholders both internal and external for sharing/learning evolution of clinical data strategies and creative ways of solving business needs.

  • Adopts and helps others to adopt changing needs of the organization in clinical data & interoperability domain.

What You Bring:

  • Bachelors degree preferred

  • 10+ years of experience in healthcare, clinical data integration/exchange, interoperability related roles.

  • 5+ years of experience with health insurance.

  • 5+ years of experience in leadership and people management

What You’ll Gain:

It is our mission at Blue Cross Blue Shield of Massachusetts to foster a culture that enables associates to do their best work while living happy and healthy lives. That's why we offer you a variety of ways to support your best physical, emotional, financial, and social well-being. For more information on our benefit offerings, visit

Minimum Education Requirements:

High school degree or equivalent required unless otherwise noted above

LocationBostonTime TypeFull time

Salary Range: $162,000.00 - $198,000.00

The job posting range is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. An employee’s pay position within the salary range will be based on several factors including, but limited to, relevant education, qualifications, certifications, experience, skills, performance, shift, travel requirements, sales or revenue-based metrics, and business or organizational needs and affordability.

This job is also eligible for variable pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance, 401(k), and a suite of well-being benefits to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, or any other form of compensation that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

WHY Blue Cross Blue Shield of MA?

We understand that the confidence gap ( and imposter syndrome ( can prevent amazing candidates coming our way, so please don’t hesitate to apply. We’d love to hear from you. You might be just what we need for this role or possibly another one at Blue Cross Blue Shield of MA. The more voices we have represented and amplified in our business, the more we will all thrive, contribute, and be brilliant. We encourage you to bring us your true colors, , your perspectives, and your experiences. It’s in our differences that we will remain relentless in our pursuit to transform healthcare for ALL.

As an employer, we are committed to investing in your development and providing the necessary resources to enable your success. Learn how we are dedicated to creating an inclusive and rewarding workplace that promotes excellence and provides opportunities for employees to forge their unique career path by visiting our Company Culture ( page. If this sounds like something you’d like to be a part of, we’d love to hear from you. You can also join our Talent Community ( to stay “in the know” on all things Blue.

At Blue Cross Blue Shield of Massachusetts, we believe in wellness and that work/life balance is a key part of associate wellbeing. For more information on how we work and support that work/life balance visit our "How We Work ( " Page.

Voted as the highest in member satisfaction among Massachusetts commercial health plans by JD Power , Blue Cross Blue Shield of Massachusetts is a community-focused, tax-paying, not-for-profit health plan headquartered in Boston. We have been a market leader for over 75 years, and are consistently ranked among the nation's best health plans. Our daily efforts are dedicated to effectively serving our 2.8 million members, and consistently offering security, stability, and peace of mind to both our members and associates.

Our Commitment to You

We are committed to investing in your development and providing the necessary resources to enable your success. We are dedicated to creating a refreshing and rewarding workplace that promotes excellence and provides opportunities for employees to forge their unique career path. We take pride in our diverse, community-centric, wellness-focused culture and believe every member of our team deserves to enjoy a positive work-life balance.

Blue Cross Blue Shield of Massachusetts is an Equal Employment Employer - veterans/disability. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Blue Cross Blue Shield of Massachusetts will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with Blue Cross Blue Shield of Massachusetts's legal duty to furnish information.

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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.
**Auto req ID:**
12521BR
**Location:**
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.
**External-Facing Title:**
Sr. Manager, Clinical Data Management
**Posting Country:**
US - United States
**Salary Range:**
$140,500 - $184,500 (Compensation could be higher based on education, experience and skill sets)
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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