Senior Trial Master File Specialist

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Evaluation
  3. United States
Gaithersburg, USA
Posting date: 12 Jan 2021
This vacancy has now expired

Proclinical is currently recruiting for a Senior Trial File Specialist with a leading biotechnology company located in Gaithersburg, MD. As the Senior Trial Specialist, you will be responsible for the oversight, management, and quality of clinical trial content, with a strong focus on oversight of the set up and routine documentation filing of the TMF to ensure adherence with the TMF Plan, SOPs, and ICH/GCP/regulatory guidelines.

Job Responsibilities:

  • Overall management and quality maintenance of essential clinical trial documents and other designated content, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs and ICH/GCP/regulatory guidelines
  • Oversight and assistance with the overall TMF completion, including appropriate content filing and maintenance, cross-functional document coordination, including third party content
  • Reviews TMF Plans and timelines; interact with CRO partners to oversee their TMF activities and review and provide feedback on performance metrics
  • Conducts and documents TMF/eTMF content reviews for quality, completeness, and other performance metrics on a regular basis to support inspection readiness
  • Maintain metadata and indexing, processing, publishing, records retention best practices
  • Work with internal functional groups to facilitate, train, and review filing of TMF content
  • Manages activities for off-site archival of TMF content
  • Provides input to TMF strategy including internal TMF SOPs or work instructions governing studies using an outsourcing model
  • Manage and organize the clinical operations and TMF content within the network file share drive
  • Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory, and other non-clinical documents, as assigned
  • Files content into electronic Trial Master File (eTMF) management systems such as Veeva Vault eTMF
  • Other duties as assigned

Skills and Requirements:

  • Bachelor's degree, preferably in a scientific discipline
  • 3 5 years or more of experience with eTMF management systems, solutions, practices, workflows
  • Working knowledge of Good Documentation Practices (GDP), Good Clinical Practices (GCP) and TMF best practices, such as the DIA Reference Model
  • Capable of working with multiple IT systems, including Electronic Document Management Systems
  • Experience with coordinating document management activities performed by internal teams and third parties, such as clinical vendors
  • Ability to manage multiple projects and effectively prioritize activity
  • Knowledge of clinical research concepts and able to work in a team environment
  • Excellent organizational and planning skills
  • Ability to build and maintain positive relationships with management and peers
  • Excellent written and verbal skills required
  • Good written and spoken English
  • Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook, Project

If you are having difficulty in applying or if you have any questions, please contact Natasha Patel at (+1) 617-778-7319 or

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.