Clinical Data Manager

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), CRA Manager, Project/Study Manager (CSM/CPM)
  3. United States
Boston, USA
Posting date: 24 May 2021

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 by attending internal and external clinical trial project team meetings.
  • Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.
  • 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 during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications.
  • 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 where protocol requirements are outside of standard CRF library versions.
  • Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
  • 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:

  • Experience in clinical data management for 7+years
  • Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
  • Medidata Rave experience required.
  • Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.

If you are having difficulty in applying or if you have any questions, please contact Bri 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.