TMF Project Lead

Job Title: TMF Project Lead

 Provides oversight of all electronic Trial Master File (TMF) management activities for assigned projects. Drives and oversees successful completion of all TMF scoped deliverables including TMF Plan development, TMF set-up, monitoring TMF document processing, with oversight and coordination of Quality Control (QC) processes including internal and external audit representation. Involved in monthly project reviews evaluating operational and financial Key Performance Indicators. 

Job Description:

• Attends Trusted Process meetings as the TMF Subject Matter Expert (SME). Successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
• Evaluates and provides recommendations on optimal TMF set-up. Drives the TMF set-up, structure, and completeness reports.
• Actively involved in Collaborative Workspace including set-up and training for the internal or external team members, as applicable.
• Collaborates with the client Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted in a timely manner with high quality to maintain the TMF in an audit-ready state. Develops plans to increase compliance and follows up on non-compliance, if applicable.
• Attends internal project team and sponsor meetings as TMF SME as applicable to the project.
• Designs and/or delivers study specific TMF training.
• Generates and provides Completeness Reports.
• Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.
• Provides regular feedback to the Project Team on TMF health/status, including actionable metrics. As necessary, provides re-training to the Project Team.
• Provides guidance to the Project Team and TMF Operations Team on performing the final QC/Completeness Review.
• Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and documents any out-of-scope work in Change Notification Form/Change Orders as required.
• Presents monthly TMF status, risks, issues and associated actions for assigned projects during the Project Review Meeting (PRM).
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Requirements/Qualifications:

• Bachelor’s degree in Life Sciences, Computer Science, Business or relevant experience required
• Experienced knowledge in working with TMF Reference Model
• Experienced knowledge in working with Veeva eTMF preferred
• 3-5 years of relevant clinical experience in a Pharmaceutical, Biotech or CRO environment preferred
• GCP and regulatory knowledge including FDA and ICH regulations
• A flexible attitude with respect to work assignments and continued industry related education
• Efficiently organizes workload of several simultaneous studies to ensure critical milestones are met, while also maintaining an expectation of quality work
• Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
• Ability to handle difficult situations professionally and maintain a professional and caring demeanor
• Proven ability to collaborate in a team environment and work independently
• Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
• Must be responsible, creative and highly motivated
• Experience with Microsoft Office Suite, Teams, Adobe, Harvest, Box, SharePoint, and Visio
• Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills
• Ability to perform several tasks simultaneously to meet deadlines

Job Type: Full-Time; occasional weekend and evening hours

Location: San Diego, CA (Work Remotely due to COVID-19)

Work Remotely:

• Temporarily due to COVID-19
• This position will be based out of our San Diego, California office. Due to the COVID-19 pandemic, this position does not currently require regular in-office work (unless otherwise directed) until after Jan, 2022 at the earliest. Employee will primarily work with our internal Project Managers and Analysts. At present time, we have discouraged travel, however, as COVID-19 restrictions are lifted, some local travel may be required, with additional limited overnight travel.
• Travel
  • Must be able to travel by car/air to other CrO Biosciences meetings and events as needed.

COVID-19 Precaution(s):

• Remote interview process