Manager, Clinical Data Manager Study Lead

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 115,000 - 187,000; Full time

Benefits offered by this job

Health benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager Clinical Data Manager Study Lead to oversee lead Data Manager(s) on assigned trials, ensuring data management deliverables meet standards and timelines.

You will partner with study teams and external partners (CROs, data vendors) for complex studies, review eCRF and database design, manage data quality, and ensure proper data transfers and reconciliation from start-up to archiving.

Qualifications

• Bachelor Degree or equivalent in Mathematics, Science or related field with 7+ years of clinical data management experience.
• Experience leading data management activities across trials and collaborating with teams and CROs.
• Knowledge of SOPs, Data Management Plans, and regulatory expectations.

Responsibilities

• Provide high level data management expertise to support clinical studies.
• Communicate requirements for eCRF and database design, data quality, and reporting.
• Oversee data quality reviews and data transfer with CROs and third parties.
• Manage data transfers, SAE/AE reconciliation, and coding with MedDRA/WHO‑DD.
• Lead DM deliverables across studies with timelines and metrics.

Skills

Data management

Study leadership

Vendor coordination

Regulatory knowledge

Education

Bachelor's degree in Math/Science

Tools

EDC systems

Data management tools

Job description

Build our future together: The Manager Clinical Data Manager Study Lead, provides oversight of lead Data Manager(s) on assigned clinical data management studies in specific therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Assists in the development of SOPs, Working Practice, Data Management Plan, and other data management standards.

When & where: Location: Remote Travel percentage: 25%

Discover your role: Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for 1 or more complex studies within a given TA. Oversee all DM activities across all stages of the trial from study start-up through archiving.

To include but not limited to the following:

• Provide a high level of expertise in data management to support clinical studies.
• Provide clear verbal or written information and hands‑on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
• Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Manage data transfers with CROs and third‑party data sources, SAE/AE reconciliation and MedDRA/WHO‑DD coding.
• Support the transfer, locking, and archiving of study databases.
• Manage scheduling and time constrains across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• Perform & document the oversight of CRO data management activities for assigned studies: Ensure the design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks are performed according to SOPs and WIs.
• Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution.
• Document DM sponsor oversight activities from protocol review through study close‑out.
• Review and approve study documentation for assigned studies, (including, but not limited to): Data Management Plan or equivalent (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non‑CRF data) Case Report Form and Completion Guidelines Validation specifications and data transfer specifications.

Lead/oversee all data management deliverables for assigned studies:

• Ensure deliverable timelines are developed according to the business need and program objectives.
• Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
• Ensure regular status updates with metrics are provided to CST.
• Provide program level input to & monitor deliverable timelines.
• Monitor data quality and assess progress of data issue remediation on an ongoing basis.
• Identify risks, propose mitigations, proactively escalates operational or DM vendor or DM CRO issues.
• May provide limited program level support for a small program with limited number of studies.

This role requires:

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field with at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance.
• Follow through on gaps until resolution, escalating as necessary.
• Lead/oversee all data management deliverables for assigned studies: Ensure deliverable timelines are developed according to the business need and program objectives.
• Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
• Ensure regular status updates with metrics are provided to CST.
• Provide program level input to & monitor deliverable timelines.
• Monitor data quality and assess progress of data issue remediation on an ongoing basis.
• Identify risks, propose mitigations, proactively escalates operational or DM vendor or DM CRO issues.
• May provide limited program level support for a small program with limited number of studies.

We are committed to building a workplace with an inclusive culture.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $114,800.00 - $187,400.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.