TMF Project Manager

Position Purpose:

  • Experience in planning and conducting GCP audits (vendor, internal process and investigator site) and may include responsibilities for providing Quality Assurance (QA) support to clinical operations teams.
  • Provide mock inspection services to clients as needed.
  • Provide operational excellence through best practices and lesson learned.

Role Description

Position Title: Trial Master File (TMF) Manager I/Manager II/Senior Manager

Reports to: President and CEO/Vice President of Clinical Operations/Project Leader/Project Manager

Location: Remote

Position Overview:

The TMF Project Manager is the single point of contact for the Client for all TMF Projects. The TMF Project Manager is responsible for:

  • Ensuring standardization, training, quality, cost effectiveness, and timely clinical trial documentation across the assigned project(s).
  • Ensuring clinical trial documentation is consistent with the Trial Master File specifications, submission/inspection readiness criteria and complies with applicable SOPs and other requirements.
  • Ensuring the consistent use and application of standards.
  • Acting as a TMF subject matter expert for commissioned projects, document content, applicable technologies and processes.
  • Ensuring a complete and accurate Trial Master File through documentation quality and consistency for all clients.

Primary Responsibilities

  • Develop or advise client on TMF specifications, including Standard Operating Procedures, TMF Plans, guidance documents or process documents.
  • Create or advise client on inspection and/or audit readiness plan for TMF content (may include applicable databases).
  • Create or advise client on document quality guidelines (which may include tools and resources).
  • Create or advise client on documentation flow activities with guidance documents as applicable.
  • Actively identify or advise client on continuous improvement opportunities to enhance operational efficiencies through process and metric analysis.
  • Create or advise client on a metrics program that can monitor performance against targets to ensure program deliverables are being met and productivity is aligned.
  • Create or advise client on document quality requirements.
  • Develop TMF training specifications that may be used internal or external to LMK.
  • Train and support new TMF Project Managers, TMF Consultants or TMF Support Analysts.

Training and Education Requirements

Candidates for the position should have the following levels of experience:

  • Minimum of Bachelor’s Degree or equivalent.
  • Clinical Documentation Management and industry experience that have provided a thorough understanding of the processes associated with conducting a clinical trials and document management operations.
  • Outstanding verbal and written communication skills, combined with outstanding listening skills.
  • History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
  • Strong skills in negotiation and conflict resolution are essential, and the ability to remain calm and focused in high-stress situations is very important.
  • Lean six sigma certification (or equivalent).
  • 7 years relevant clinical research experience with an understanding of clinical drug development and clinical trials operations
  • 1-2 years CRO experience

Request a complimentary consultation.