Clinical Documentation Specialist

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Project/Study Manager (CSM/CPM), Program Manager / Director
  3. United States
Boston, USA
Posting date: 18 Mar 2021

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

Job Responsibilities:

  • May act as eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding
  • Manage askTMF mailbox and maintenance of an FAQ log
  • Support Study EDLs and Milestones configuration and management TMF Quality
  • Create and manage Study TMF Filing plan with input from Study team
  • Support TMF review process by working closely with study teams, CROs and Vendors
  • Preform assigned TMF review actions in a timely manner

Skills and Requirements:

  • Bachelor's Degree or equivalent with demonstrable related experience in pharmaceutical / biotechnology industry including records management experience in a GCP-regulated environment
  • Good working knowledge of the TMF Reference Model
  • Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF

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.