Sr Clinical Data Manager

Local Jobs Vertex Pharmaceuticals
  • United States, Boston, MA 02210 View on Map
  • Post Date: June 18, 2020
  • Apply Before : July 18, 2020
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Job Description

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

Minimum Qualifications

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

Preferred Qualifications

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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