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Title:Contract- Clinical Data Manager
Salary:Open
Experience:3+
Location:MA - Cambridge

Description:
Review clinical study protocols and provide input.

Responsibilities:
  • Develops CRFs for new and complex projects.
  • Develops study – specific procedures, metrics, listing specifications and Electronic Data handling processes.
  • Conducts cross-functional Formatted Data Review.
  • Develops and maintains Data Management study timeline.
  • Oversees vendor DM activities, including timeliness and quality of deliverables.
  • Reviews statistical tables and listings and Clinical Study Reports.
  • Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team.
  • Plans and oversees development of Data Management Plans, Data Entry Guidelines, CRF Completion Guidelines,Data Review Guidelines, and eCRF help text Plans, performs, and oversees development of specifications for eCRFs, Edit Checks, electronic data handling, and manual review.
  • Plans and oversees execution of User Acceptance Testing.
  • Prepares and delivers presentations at internal and external meetings.
  • May oversee activities of a CDM team on a study.
  • May define and manage CDM project timelines on a study, evaluate and mitigates risks.
  • May be responsible for all aspects of the CDM study deliverables on a smaller-scope studies.
  • May review vendor RFIs, RFPs, proposals and contracts and provide input.
  • Provides input regarding project resource requirements and timelines.
  • May supervise other Clinical Data Management staff.
  • Performs other duties as assigned.

Requirements:
  • Has a good understanding of Good Clinical Data Management practices, cross-functional roles and responsibilities
  • Demonstrates working knowledge and efficient use of EDC systems and processes, familiarity with industry standards
  • Demonstrates effective communication skills, especially in peer-directed presentations
  • Able to successfully work on a team and or independently
  • Displays sound project management skills and ability to prioritize workloadSubject 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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