What are the responsibilities and job description for the Senior Manager of Clinical Research position at Regeneron Pharmaceuticals?
Program Director Role
The Program Director of Data Operations oversees data management activities and decisions including quality, timelines, and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP guidelines, and company Standard Operating Procedures (SOPs) within assigned program(s).
This individual is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM), interacting with senior-level management, external vendors, team partners, and clinical study personnel for clinical research project and department initiatives.
Key Performance Indicators
- Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM) within the Hematology/Oncology Therapeutic Area.
- Leads 3-5 direct reports and runs one study.
Maintains an overview of clinical program(s) status and issues, proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and/or process. Provides CDM program-level updates to collaborators as requested.
Responsibilities
- Reviews plans and provides CDM expertise during protocol design, study startup, and conduct phases of studies.
- Ensures consistency within the program and development of standard methodologies within CDM.
- Ensures use of standards for data collection and cleaning.
- Ensures quality results, implements timelines, and is accountable for ensuring consistency of process and approaches across clinical study results.
- Leads all aspects of program-level result timelines, ensuring proper resources are in place and supervising overlapping deliverables.
- Is responsible for CDM study budgets within a program, ensures review of initial study budget, and handles the budget through the lifecycle of the program by communicating changes as appropriate.
