Manager, Clinical Data Manager Study Lead

Build our future together: 

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. Assists in the development of SOPs, Working Practice, Data Management Plan, and other data management standards.  

When & where: 

• Work Location: Remote 

• 25% Travel may be required 

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. 

• Escalate and follow to resolution as necessary. 

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 

This role requires: