Trial Master File Specialist - (Clinical Documents /Global Trials) – Pharma - Contract to Start/Top $$

Job Type: 
Professional Services
Life Sciences
Other Life Science Positions
Employment Category: 

Our client, a growing RTP-area pharmaceutical company with both marketed products as well as products in development, is actively recruiting for a detail-oriented clinical document control specialist who will manage the Trial Master File (TMF). . 

This position will begin as contract with strong possibility of converting to direct hire for a stellar performer.  Company will pay industry-leading wage to attract an excellent candidate.

This company is building.  The TMF Specialist will be involved in supporting all phases of clinical development including creating, maintaining and auditing of the TMF for submission and inspection readiness, as well as indexing, tracking and filing of paper and electronic clinical trial documents.  Thorough knowledge of global clinical trial documents, as well as ICH and GCP guidelines will be needed 

Specific duties will include:

•             Responsible for Trial Master File set up and quality management / maintenance

•             Assist with the setup, organization, and maintenance of study-specific TMFs, clinical trial management systems (CTMS), trial master files (TMFs) and internal document repositories

•             Maintain, update and become a subject matter expert on Company’s standard TMF index

•             Maintain and archive paper files, maintain inventory listings and retrieve documents in a timely manner

•             Provide oversight of the set-up, maintenance, archiving and on-going quality review of TMFs that are managed by external partners and vendors

•             Conduct periodic internal reviews and audits of TMFs

•             Assist in the preparation, handling, distribution, filing and archiving of clinical documentation and reports per standard operating procedures.

•             Assist in review and writing of SOPs and Departmental Policies and Procedures as it relates to TMF maintenance and archiving

Targeted candidate will offer a related degree (BS expected) and 3+ years of clinical document (TMF) control experience in pharma, biotech or CRO.  Global clinical trial experience will be needed. 

In addition, we seek an independent, knowledgeable and flexible professional who will work exceedingly well in a dynamic and collaborative setting; One who can adapt to changing priorities and one who has the ability to take initiative to complete tasks under tight deadlines.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.