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The Manager, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice. The Manager will assist to guide the strategy and lead the delivery of department objectives in ensuring the management of the essential documents.
Key Responsibilities & Duties
• Fulfill the TMF Process Owner role
• Prepare periodic TMF Quality Control checklists for review by Project Team review
• Review of TMF metrics and spreadsheets for studies
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
• Ensure TMF Compliance Milestones are adhered to during the entire study
• Provide input into departmental resourcing requirements
• Communicate directly with multiple Project Team members to assess project needs relevant to the TMF
• Provide regular updates on TMF Compliance to Project Teams and Sponsors as necessary
• Ensures successful delivery of the TMF Operations Key Performance Indicators
• Participates in and directs activities related to department staff operations such as interviewing and selection, professional development, training, performance management, and employee counseling and separations.
• Assigns resources and manages transitions of ongoing studies/processes/workflows.
• Designs and/or delivers TMF training in various formats via teleconference, video conference, and/or in person.
• Actively involved and/or leads department and business unit improvement initiatives.
• Review SOPs and supporting documents for compliance with relevant SOP, legislation, and industry best practice
• Lead TMF activities during regulatory inspections and Sponsor audits
Requirements:
Bachelor’s Degree (Science preferred)
5-8 years of relevant experience working with an eTMF
TMF Manager experience preferred
Experience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
Experience of Document Management and/or eTMF solutions (e.g. Veeva, Phlexglobal, Trial Interactive, Documentum, etc.)
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.