Clinical Document Specialist (TMF Specialty) – Contract to Start/Pharma

Life Sciences
Job Type: 
Life Sciences
Clinical Research and Development
Other Life Science Positions
Professional Services
Employment Category: 
Temp To Hire

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

Key things to note:

  • The focus of this role with be Trial Master File document control.  We seek a specialist in this function.
  • The 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 both manual Doc Control systems and electronic document systems.  Seek candidate with the knowledge and capability to successfully navigate in both.
  • 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.

Specific duties will include:

  • Responsible for Trial Master File set up and quality maintenance for multiple clinical trials
  • Assist with the setup, organization and maintenance of study-specific Trial Master Files, clinical trial management systems and internal document repositories
  • Maintain and archive paper files and maintain inventory listings
  • Conduct periodic internal reviews of TMFs in accordance with SOPs, providing support in the preparation, conduct and follow-up of external audits and inspections.
  • Provide oversight for set up, maintenance, archiving and on-going quality review of TMFs or eTMFs that are managed by external vendors
  • Assist in the preparation, handling, distribution, filing and archiving of clinical documentation and reports
  • Attend project team, department, and non-study specific meetings, to include distribute and generate meeting agendas and minutes as requested
  • Establish and maintain effective communication and collaboration with cross functional peers and teams

Targeted candidate will offer a 4 year degree (or equivalent experience) and 2+ years of pharmaceutical development and clinical document (TMF) control experience in pharma, biotech or CRO. 

Other priorities include:

  • Global clinical trial experience
  • Knowledge of GCP and ICH requirements and guidelines
  • Demonstrated ability to help develop SOPs for Clinical Document/TMF Control.
  • FDA inspection experience
  • Proficiency in computer software databases and systems.

Finally, we seek an highly motivated self-starter who can take initiative.  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.