• Provide guidance to Clients on TMF Standard Operating Procedures, processes, best
practices and technology.
• Offer direction and support on TMF training.
• Provide operational excellence through best practices and lesson learned.
Position Title: Trial Master File (TMF) Consultant I/Consultant II/Principal Consultant
Reports to: President and CEO/Vice President of Clinical Operations/Project Leader
The TMF Consultant will be the single point of contact for the client for all TMF projects. The TMF Consultant will:
- Ensure clinical trial documentation is consistent with the Trial Master File Specifications, submission/inspection readiness criteria and complies with applicable SOPs and other requirements.
- Provide guidance to support how to obtain consistency through the use and application of standards.
- Act as a TMF subject matter expert on applicable technologies and processes used by the client.
- Provide complete TMF services for custom development and business process outsourcing for Clients.
- Develop the post implementation go-live support environment, construct the transition plan from the project team to the support team, and support and maintain the client applications and technology infrastructure.
- 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 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