Clinical Document Specialist/Manager (TMF /Global Trials) – Pharma/Top $$

Job Type: 
Life Sciences
Other Life Science Positions
Employment Category: 
Contract

Our client, an RTP pharmaceutical company in high growth mode, is actively recruiting for a very sharp, capable and industrious candidate to assume key role on its Clinical team.  Position will focus on enhancing and maintaining its Document Management/TMF systems.  Company will pay an excellent wage to attract and retain the right candidate.

Key things to note:

  • This company has marketed products as well as a rich pipeline, including one product that is near-launch.  The future is very bright.
  • This position will begin as contract with strong possibility of converting to direct hire.  Seek candidate with a long-term view.  This is an on-site role.
  • Company is running global trials and similar exposure will be important.
  • Currently, the company uses a manual/paper Doc Control system.  Seek a candidate with the knowledge and capability to help the company select and implement an eTMF system.
  • The company is in building mode.  Right candidate will enjoy an empowered and dynamic setting in which he/she can contribute broadly and help set direction.

Position will involve 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 and 3+ years of clinical document (TMF) control experience in pharma, biotech or CRO.  Global clinical trial experience will be important. 

In addition, we seek a candidate with the demonstrated ability to develop SOPs for Clinical Document/TMF Control, including selecting and implementing an eTMF system.  We need a leader who can drive this effort.

Finally, 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.