Trial Master File Manager III

eTMF Administration

• Support eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding
• Act as Subject Matter Expert for eTMF management
• Ensure suitable reports and outputs are built to support TMF Quality
• Oversee the management of askTMF mailbox and FAQ log

TMF Quality

• Create and manage Study TMF Filing plan with input from Study team
• Provide day to day document management support
• Support TMF review process by working closely with study teams, CROs and Vendors
• Ensure Study EDLs and Milestones are configured and maintained
• Perform and manage TMF Quality reviews and drive for constant inspection readiness of TMFs
• Serve as point of contact and support study teams for resolution of TMF-related queries or quality issues
• Act as point of contact to support TMF audits and inspections as required

Paper TMF

• Oversee the Set-up of TMF paper folders and management of inventory trackers
• Ensure the CRO’s portion of the TMF is processed in a timely and controlled manner
• Support the management and tracking of TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies

TMF Archiving

• Oversee the preparation of TMF records (paper and electronic) for long-term, off-site archival in compliance with company procedures, GCP and other relevant global regulatory requirements
• Oversee the quality checks and retrievals testing of TMF records from long-term archival
• Participate in independent audits of external archive facilities, as applicable

Process Improvement and Training

• Author, contribute to, maintain and implement TMF Management Controlled Documents and associated resources (e.g. training materials, knowledge databases)
• Support and/or deliver training across CRO and Vendors on the policies and procedures relative to and for TMF management
• Foster positive relationships with external vendors and internal clinical development areas
• Work with Strategic CRO Partners on the continued development of TMF and Record Management practices and expectations

Skills

• Bachelor’s Degree or relevant demonstrable related pharmaceutical / biotechnology industry experience including records management in a GCP-regulated environment
• 6-9 years as TMF manager with prior eTMF Specialist experience
• Strong working knowledge of the TMF Reference Model
• Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
• Experience of electronic document management system(s) and Veeva eTMF preferred
• Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred
• Strong interpersonal skills and ability to manage at all levels within a cross-functional organization through influence
• Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude
• Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
• Ability to handle a high volume of complex tasks within a given timeline
• Clear alignment with Core Values:
• Commitment to People
• Innovation and Discovery
• Sense of Urgency
• Open Culture
• Passion for Excellence

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.