Clinical Data Manager

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), CRA Manager
  3. United States
Boston, USA
Posting date: 13 Nov 2020
CR.BC.34153

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

Job Responsibilities:

  • Serve as lead CDM on assigned clinical trials
  • Responsible for the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials.
  • Provide ongoing operational support for Medidata RAVE activities
  • Provide ad-hoc report development, and support database lock and archiving activities.
  • Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies
  • Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
  • Participate in the development of standard operating procedures (SOPs).
  • Mentor junior staff on clinical data management activities and procedures.
  • Provide guidance to clinical data management personnel on assigned projects, reviewing study documents as needed, e.g. Data Management Plan, Operational Plan for database locks
  • Ensure project documentation is being archived in a timely manner into the Trial Master File.

Skills and Requirements:

  • Bachelor's Degree and 7+ years of relevant experience
  • Knowledge of Microsoft Office and Medidata RAVE
  • Vendor management skills
  • Experience with CDASH terminology and/or MedDRA and WhoDrug coding

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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