Clinical Data Project Manager

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Program Manager / Director, VP/Head of Clinical Operations
  3. United States
Cambridge, USA
Posting date: 19 Nov 2020
CR.BC.34310

Proclinical is currently recruiting for a Clinical Data Project Manager with a pharmaceutical company located in Cambridge, MA.

Job Responsibilities:

  • Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and sponsor for all data related deliverables, especially in support of key decision points and regulatory submissions.
  • Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
  • Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
  • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc.
  • Participates and represents function in formal inspections and audits as requested.

Skills and Requirements:

  • BS/BA required preferably in a health-related, life science area and with a minimum of 10 years data management and/or drug development experience.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Proven track record of strong project management skills
  • Experience with all phases of development and at least 2 therapeutic areas

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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