34,514 Clinical jobs in the United States

Director Clinical Operations Study Management

Salary: $225,000 - $45,000

New York City or Jersey City (Hybrid)

Job Description

Founded by a team of noble prize winning scientists, EPM is partnered with one of the most exciting and cutting edge biotech companies in the industry. They have raised over 1 billion dollars of funding to advance their pipeline of 7 programs and are gearing up for their first Phase 3. Focusing in oncology, they are using a first of it's kind drug discovery platform that has allowed them to create the most innovative drugs ever seen.

Responsibilities

• Responsibility for the overall management of assigned clinical programs across multiple studies
• Providing strategic direction to study teams to ensure timely execution of clinical trials
• Have a key role in hiring/resourcing plans, program budgets, hiring process of study team
• Responsible for day-to-day management of assigned direct reports
• Oversight of CRO and other key vendors to ensure timely and quality deliverables
• Act as point of escalation for clinical trial execution issues
• Oversight of the set-up and implementation of effective investigator and site monitor training
• Leadership and implementation of infrastructure initiatives, process improvements, change management, and business projects
• Oversight of the clinical aspects of timely data cleaning, data analysis, and the availability of top line resutls

Qualifications

• Bachelor's degree required
• 12+ years of experience working with CROs to manage large scale global clinical trials
• Oncology experience is required
• 4+ years of experience managing direct reports, displaying strong leadership, team building, and hands-on management
• Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices
• Effective communication and interpersonal skills
• Excellent organizational skills and attention to detail
• Able to work independently while exercising initiative, flexibility, and sound judgement
• Experience monitoring all types of data

Benefits

• Medical
• Dental
• Vision

Director, Clinical Operations Study Management Join to apply for the Director, Clinical Operations Study Management role at Eikon Therapeutics Director, Clinical Operations Study Management 1 day ago Be among the first 25 applicants Join to apply for the Director, Clinical Operations Study Management role at Eikon Therapeutics Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position The Director of Clinical Operations Study Management will be responsible for overseeing the execution of multiple global clinical trials in oncology and other therapeutic areas, as required. You will lead a diverse team, ensuring the successful planning, coordination, and management of clinical trials in compliance with regulatory standards and company objectives. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require), in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are a collaborative, agile leader with significant oncology global clinical development experience, and have a passion for operational excellence, building and leading inhouse clinical operations and FSP study management teams. You possess a deep understanding of clinical trial regulations, guidelines, and the principles of Good Clinical Practice (GCP), ensuring strict compliance throughout the clinical trial process. What You’ll Do In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operational delivery of protocols. Oversee clinical study planning, execution, and closeout activities, ensuring compliance with all applicable regulations, guidelines, and company policies. Provide strategic guidance and direction to cross-functional study teams to ensure successful study execution. Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines. Manage study budgets, timelines, and resource allocation to ensure successful completion of studies. Develop and maintain strong relationships with study investigators, clinical vendors and other external partners. Provide regular updates on study progress to senior leadership and other stakeholders. Ensure that all study-related documents are accurate, complete, and filed appropriately. Serve as a talent magnet, to manage, develop, coach and retain top Clinical Operations talent in the study teams. Set clear performance standards and hold self and organization accountable for achieving high quality, high impact results. Embrace metrics and high-performance standards. Qualifications Typically requires a minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree Experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry highly preferred. Significant experience managing international clinical studies in oncology, and directly managing global Clinical Operations personnel. Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment. High emotional intelligence. Exceptional communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to senior leadership is required. In-depth knowledge of ICH-GCP, EMEA, PMDA guidelines and other relevant regulations and guidelines. Proven ability to manage international clinical studies within timelines and budget while maintaining high quality standards and patient safety. Strong leadership, with a demonstrated ability to work collaboratively with cross-functional teams across diverse cultures and global regions. Management expertise should cover management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery. Veeva clinical systems experience preferred. MS Project experience preferred. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $226,000 to $47,000 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Eikon Therapeutics by 2x Get notified about new Director Clinical Operations jobs in Jersey City, NJ . Woodbridge, NJ 127,500.00- 172,500.00 5 days ago Director of Operations - Ambulatory Healthcare New York, NY 160,000.00- 180,000.00 1 day ago Vice President of Clinical Operations (Remote) New York, NY 120,000.00- 150,000.00 1 week ago New York, NY 175,000.00- 200,000.00 2 weeks ago Vice President, Global Clinical Operations Bronx, NY 105,000.00- 110,000.00 1 year ago Director of Healthcare Coalition Operations, Bureau of Healthcare and Community Readiness Director, Clinical Operations Study Management Senior Program Director, Certified Community Behavioral Health Clinic New York, NY 130,000.00- 133,000.00 6 days ago New York, NY 150,000.00- 180,000.00 2 weeks ago New York City Metropolitan Area 17 hours ago New York City Metropolitan Area 1 month ago Director of Operations – Behavioral Health Clinic Queens, NY $1 0,000.00- 135,000.00 3 weeks ago New York, NY 153,500.00- 170,500.00 1 week ago Director of Education and Clinical Excellence Greenvale, NY 140,000.00- 160,000.00 2 weeks ago Queens, NY 130,000.00- 133,000.00 2 weeks ago Associate Director/Director of Clinical Operations Richmond, NY 105,000.00- 135,000.00 4 months ago Clinical Director - Outpatient Mental Health Facility Director, Clinical Transformation, Corporate Business Operations New York, NY 145,000.00- 225,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Director, Clinical Operations Study Management Join to apply for the Director, Clinical Operations Study Management role at Eikon Therapeutics Director, Clinical Operations Study Management 1 day ago Be among the first 25 applicants Join to apply for the Director, Clinical Operations Study Management role at Eikon Therapeutics Get AI-powered advice on this job and more exclusive features. Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position The Director of Clinical Operations Study Management will be responsible for overseeing the execution of multiple global clinical trials in oncology and other therapeutic areas, as required. You will lead a diverse team, ensuring the successful planning, coordination, and management of clinical trials in compliance with regulatory standards and company objectives. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require), in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are a collaborative, agile leader with significant oncology global clinical development experience, and have a passion for operational excellence, building and leading inhouse clinical operations and FSP study management teams. You possess a deep understanding of clinical trial regulations, guidelines, and the principles of Good Clinical Practice (GCP), ensuring strict compliance throughout the clinical trial process. What You’ll Do In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operational delivery of protocols. Oversee clinical study planning, execution, and closeout activities, ensuring compliance with all applicable regulations, guidelines, and company policies. Provide strategic guidance and direction to cross-functional study teams to ensure successful study execution. Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines. Manage study budgets, timelines, and resource allocation to ensure successful completion of studies. Develop and maintain strong relationships with study investigators, clinical vendors and other external partners. Provide regular updates on study progress to senior leadership and other stakeholders. Ensure that all study-related documents are accurate, complete, and filed appropriately. Serve as a talent magnet, to manage, develop, coach and retain top Clinical Operations talent in the study teams. Set clear performance standards and hold self and organization accountable for achieving high quality, high impact results. Embrace metrics and high-performance standards. Qualifications Typically requires a minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree Experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry highly preferred. Significant experience managing international clinical studies in oncology, and directly managing global Clinical Operations personnel. Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment. High emotional intelligence. Exceptional communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to senior leadership is required. In-depth knowledge of ICH-GCP, EMEA, PMDA guidelines and other relevant regulations and guidelines. Proven ability to manage international clinical studies within timelines and budget while maintaining high quality standards and patient safety. Strong leadership, with a demonstrated ability to work collaboratively with cross-functional teams across diverse cultures and global regions. Management expertise should cover management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery. Veeva clinical systems experience preferred. MS Project experience preferred. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $226,000 to $47,000 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Eikon Therapeutics by 2x Get notified about new Director Clinical Operations jobs in New York, NY . Woodbridge, NJ 127,500.00- 172,500.00 5 days ago Director of Operations - Ambulatory Healthcare New York, NY 160,000.00- 180,000.00 1 day ago Vice President of Clinical Operations (Remote) New York, NY 120,000.00- 150,000.00 1 week ago New York, NY 175,000.00- 200,000.00 2 weeks ago Vice President, Global Clinical Operations Bronx, NY 105,000.00- 110,000.00 1 year ago Director of Healthcare Coalition Operations, Bureau of Healthcare and Community Readiness Senior Program Director, Certified Community Behavioral Health Clinic New York, NY 130,000.00- 133,000.00 6 days ago New York, NY 150,000.00- 180,000.00 2 weeks ago Director, Clinical Operations Study Management New York City Metropolitan Area 17 hours ago Director of Operations – Behavioral Health Clinic Queens, NY $1 0,000.00- 135,000.00 3 weeks ago New York City Metropolitan Area 1 month ago New York, NY 153,500.00- 170,500.00 1 week ago Director of Education and Clinical Excellence Queens, NY 130,000.00- 133,000.00 2 weeks ago Greenvale, NY 140,000.00- 160,000.00 2 weeks ago Associate Director/Director of Clinical Operations Richmond, NY 105,000.00- 135,000.00 4 months ago Director, Clinical Transformation, Corporate Business Operations New York, NY 145,000.00- 225,000.00 2 weeks ago Clinical Director - Outpatient Mental Health Facility We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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:

Education
Bachelor's degree in science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experience

Experience
•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 week
There are international calls/meetings once or twice a week.
Requires up to 10% of domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It 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.

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Kyowa 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.

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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.PositionNurix 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.SummaryThe 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 closeoutManage 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 timelinesEnsure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with trainingWork collaboratively with internal and external team members within the study to coordinate the planning and execution of clinical data management activitiesCreate strategies for rapid study start and database lock to increase clinical data management productivityLead 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 plansEnsure 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 needsCollaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standardsHelp establishing CDM processes and contribute to the development of key clinical data management SOPsProvide technical support and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specificationsPerform budget review and guidance for clinical data management CRO for assigned trialQualificationsBachelor'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 preferredMinimum of 10 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Associate Director levelMinimum of 12 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Director levelDirect experience working with Medidata Rave design and implementationProficient on regulatory requirements for clinical data management and the regulatory submission processExtensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor's capabilities and ensuring the desired high-quality deliverablesDemonstrated 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 expertiseAble to adapt quickly to the changing needs of the organizationAble to organize multiple work assignments and establish prioritiesExcellent verbal and written communications skills; able to communicate proactively and effectivelyNurix 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 (

What we need

The Associate Director of Clinical Data Management will be a key leader in executing BCBSMAs 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.

Were 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 Youll 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

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.

Location

Time Type

Weekly Hours

Grade of Position

Number of Openings Available

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 employees 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 Companys sole discretion, consistent with the law.

WHY Blue Cross Blue Shield of MA?

We understand that theconfidence gap andimposter syndrome can prevent amazing candidates coming our way, so please dont hesitate to apply. Wed 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. Its 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 ourCompany Culturepage. If this sounds like something youd like to be a part of, wed love to hear from you. You can also join ourTalent Communityto 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.

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:

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.