Regeneron

Manager, Clinical Data Manager Study Lead

Remote - United States

Sponsorship not specified$115k-$187kDetected 1 day ago

About the role

Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
Prepare recommendations for new or improved processes for data management and data flow.

The Manager CDM, 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.
Provide a high level of expertise in data management to support clinical studies.
Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding.
Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness
Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
May provide limited program level support for a small program with limited number of studies

Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution.
Escalate and follow to resolution as necessary.
Case Report Form and Completion Guidelines
Validation specifications and data transfer specifications

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

Document DM sponsor oversight activities from protocol review through study close-out

This listing is sourced directly from Regeneron's careers page and normalized into a canonical job model.