The Senior Clinical Data Manager is an individual contributor performing complex data management tasks independently. The Senior Clinical Data Manager plays a key role on multiple moderate to complex studies. In addition, the Senior Clinical Data Manager manages external vendors on assigned studies. Key Responsibilities:
Develops, or plans and oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, Cross- functional Data Review Plan, with input from cross-functional study team
Plans and oversees execution of User Acceptance Testing. Defines Electronic Data Transfer Specifications
Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team
Reviews clinical study protocols and provides input
Reviews vendor RFIs, RFPs, proposals, and contracts and provide input
Prepares and delivers presentations at internal and external meetings
Oversees activities of a CDM team on multiple studies, including internal staff and vendors
Evaluates and mitigates risks to timelines and quality
Provides input regarding project resource requirements
Responsible for all aspects of the CDM study deliverables
May mentor other clinical data management staff
Performs other duties as assigned
Prefer B. S. (or equivalent degree) in a scientific or allied health field and solid relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
Subject Matter Expert in EDC-related tools and processes
Demonstrates well-developed instincts and problem-solving skills in all areas of data management
Understands cross-functional team roles within Clinical Development
Able to provide some leadership on a cross-functional team and work effectively in a matrix environment
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