Senior Manager, Clinical Data Management

The Senior Manager CDM, Solid Tumor Oncology - 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. The Sr Manager Clinical Data Management may be responsible for line management of clinical data management staff, which would include responsibility for staff recruitment, development, coaching, mentoring, and performance management.

As a Senior Manager, Clinical Data Management, a typical day may include:

• Serve as an Oncology DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for multiple trials 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 timeo constrains across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• May provide limited program oversight for small program with limited number of studies.
• May assist Program Lead on large programs to support Program oversight activities. 
• Interact cross-functionally and provide project leadership for SDMs within the program and for direct reports.
•  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 /  Data transfer specifications.
• Ensure the eTMF documentation is maintained on a regular basis for assigned studies:
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance.
• Follow through on gaps until resolution, escalating as necessary.
• For assigned Program(s), verify completion of IRRs and Quality Issues or gaps resolutions for data management activities and documentation.
•  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 escalate operational or DM vendor or DM CRO issues. 
• For assigned Program, verify oversight of data management deliverables
• For Direct reports verify oversight of data management deliverables.
• Ensure deliverable timelines are developed according to the business need and program objectives. 
• Oversees completion of Inspection Readiness Review (IRR) and Quality Issues or gap resolutions for data management activities and documentation. Attends Inspections/audits as required.
• Fulfill the SME role for a minimum of 1 or more topics.
• Develop and deliver SME specific training.
• Provide ongoing support for the DM organization & key stakeholders (as applicable).
• Lead