Manager, Clinical Data Management Study Lead
About The Position
The Manager, Clinical Data Management (CDM) Study Lead provides oversight of lead Data Managers on assigned clinical data management studies in specific therapeutic areas, ensuring that data management deliverables are properly planned and executed, meet Regeneron standards, and are completed within timelines. The role also assists with developing standard operating procedures, working practices, Data Management Plans, and other data management standards. The study lead serves as the primary data management contact for clinical study teams and external partners, including data vendors and CROs, on one or more complex studies. The role provides expertise and hands-on support in areas such as eCRF and database design, data quality, and reporting of database and data-quality status. It oversees data-quality review and data acceptance before analyses or database lock, manages data transfers and safety and medical coding reconciliations, and supports database transfer, locking, and archiving. The position also performs and documents sponsor oversight of CRO data management activities from protocol review through study close-out. It leads or oversees study data management deliverables, timelines, snapshot and lock plans, status reporting, data-quality monitoring, and issue remediation. The role identifies risks and process or performance gaps, recommends improvements, proposes mitigations, and escalates issues through resolution. The position is remote, with travel of up to 25% potentially required.
Requirements
- Bachelor’s degree or equivalent experience in Mathematics, Science, or a related field.
- At least 7 years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
- Ability to perform quality review and inspection-readiness tasks to meet quarterly IRR compliance.
- Ability to follow through on gaps until resolution and escalate as necessary.
Responsibilities
- Serve as the data management study lead and primary point of contact for clinical study teams and external partners, including data vendors and CROs, for one or more complex studies.
- Provide data management expertise and hands-on support to project team members and CROs regarding eCRF and database design, data quality, and database or data-quality status reporting.
- Oversee procedures for data-quality review and data acceptance before 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 transfer, locking, and archiving of study databases.
- Manage schedules and time constraints across multiple projects.
- Prepare recommendations for new or improved data management and data-flow processes.
- Perform and document oversight of CRO data management activities for assigned studies, from protocol review through study close-out.
- Ensure electronic case report forms, clinical trial databases, and electronic edit checks are designed, implemented, and maintained according to SOPs and working instructions.
- Identify data-quality, CRO-performance, documentation, and process-execution gaps; take accountability for resolution and escalate and follow issues through to resolution as necessary.
- Lead or oversee all data management deliverables for assigned studies.
- Ensure deliverable timelines are developed according to business needs and program objectives.
- Ensure snapshot and database-lock plans are developed and collaborate with the clinical study team (CST) for review and approval.
- Provide regular status updates and metrics to the CST.
- Provide program-level input to deliverable timelines and monitor them.
- Monitor data quality and assess progress in remediating data issues on an ongoing basis.
- Identify risks, propose mitigations, and proactively escalate operational, data management vendor, or CRO issues.
- Perform quality review and inspection-readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance.
- Assist in developing SOPs, working practices, Data Management Plans, and other data management standards.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits; availability depends on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
