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Clinical Data Manager

Inman Square, MA 02139 | Work from home flexibility

Posted: 07/11/2024 Employment Type: Contract Industry: Clinical Operations Job Number: 9787 Pay Range: $80-$100/hr Department: Life Science Job Setting:

Job Description

  • Act as primary liaison between Company and CRO for Data Management.
  • Provide support and oversight for the CRO Data Management team.
  • Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs.
  • Review clinical study protocols and provide comments if any.
  • Provide leadership and support for cross-functional tasks, processes, and training.
  • Provide oversight and manage relationships with external vendors.
  • Responsible for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data transfer specifications, data issue logs, data review plans and ensures all documents follow study design and regulatory requirements.

  • BS or MS degree or higher in science or related discipline.
  • Minimum of 9 years of CDM experience in pharmaceutical/biotech industry.
  • Practical experience with successful submissions and product approvals from global regulatory authorities  across multiple therapeutic areas.
  • Experience with Medidata Rave.

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About Inman Square, MA

Ready to jumpstart your career in the vibrant Inman Square, Massachusetts area? Nestled in the heart of Cambridge, this dynamic neighborhood is a melting pot of creativity, innovation, and opportunity. With easy access to eclectic dining options, such as the legendary Christina's Ice Cream, and nearby cultural hubs like the Central Square Theater and the Harvard Art Museums, Inman Square is a haven for those seeking a work-life balance in a charming and diverse community. Join us in exploring the job listings tailored to this bustling area and take your career to new heights in this enchanting locale!