Careers – Project Manager

Missions/Goals

• Ensure that all projects are delivered on-­‐time, within scope and within budget.
• Support inspection services to clients as needed.
• Provide operational excellence through best practices and lesson learned.

Position Purpose

The TMF Project Manager is the single point of contact for the Client for all TMF Projects.   The TMF Project Manager is  also  responsible  for  ensuring  standardization, training, quality, cost effectiveness, and timely clinical trial documentation  across  the  assigned  project(s).   The  clinical  trial  documentation must be consistent with the Trial Master File Specifications, submission/inspection  readiness  criteria  and  comply  with  applicable  SOPs  and other requirements. The TMF Project Manager will ensure the consistent use and application of standards. The TMF Project Manager will act  as  a  TMF  subject  matter  expert,  document  content  expert,  applicable  technologies, and processes. The ultimate objective is to ensure a complete  and  accurate  TMF  through  documentation  quality  and  consistency for all Clients.

Training & Education Preferred

Candidates for this job should have the following levels of experience:
Minimum of Bachelors Degree or equivalent required.
Clinical Documentation Management and industry experience in order to
have a thorough understanding of the processes associated with
conducting a clinical trials and document management operations.
Outstanding verbal and written communications skills, combined with
outstanding listening skills are required. History of achievement in a
customer service role with demonstration of meeting customer needs and
concerns. Strong skills in negotiation and conflict resolution essential, and
the ability to remain calm and focused in high-stress situations are very
important.
• Ideally Project Management qualified e.g. PMP / equivalent
• 4 years of experience managing projects
• 1-2 years of CRO experience
• 5 years relevant clinical research experience with an understanding of
clinical drug development and clinical trials operations

Role Description

Position Title: Trial Master File (TMF) Project Manager
Reports to: President and CEO/Vice President of Clinical Operations/Project Leader/Project Manager
Location: Remote/Clients Office

Primary Duties

• Develop and assist with the implementation of the TMF specifications.
• Ensure that the TMF specifications and inspection readiness strategy are consistent across the program and meet minimum standards.
• Ensure consistent use of standardized processes and technology across studies/programs.
• Serve as the single point of contact for internal and external audits of TMF related processes and activities.
• Review document quality data and audit outputs to identify trends across
the programs to ensure quality documentation.
• Ensure documentation flow across the program is within projected timelines and intervene to implement corrective actions.
• Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
• Review metrics to monitor performance against targets to ensure program deliverables are being met and productivity is aligned with LMK expectations.
• Support study team to ensure document quality requirements are agreed to and met, prior to reporting.
• Ensure complete TMF is in place at time of study close/submission
• Analyze error trends in documentation and provide feedback, to enable continuous improvement.
• May train and support new TMF Project Managers
• Ability to travel as necessary (approximately 25%)
• Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Ability to multi-­‐task, meet deadlines, and work effectively in a fast-­‐paced environment with competing priorities.