Description

The Trial Master File (TMF) Specialist is responsible for the overall management, quality and maintenance of essential clinical trial and other designated documents, including oversight of the vendor’s set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence to TMF Plans, SOPs, and ICH/GCP guidelines. This position plays a key role in inspection readiness and electronic global TMF system management by overseeing the organization and maintenance of electronic records and coordinating the document management activities performed by vendors as well as internal team members.

This role reports to Vice President of Clinical Operations.

Responsibilities

• Manages processes and procedures for TMF management, review, transfer, and archival of records and ensures consistency in process across all programs and studies
• Oversees vendors to ensure that TMF records are filed in a timely manner, in accordance with associated milestones
• Ensures TMFs are in a continuous state of inspection readiness
• Assists study teams with the development of study specific TMF Plans and provides input
• Conducts periodic reviews of the TMF to ensure core metrics for completeness, timeliness, and quality of the TMF are met
• Runs project specific metrics; identifies trends, risks, quality concerns, and associated actions and oversees resolution of any issues
• Performs a final TMF review following study close-out activities, identifies issues/findings, and completes remediation and/or corrective actions for TMF closure and archival
• Coordinates end of study TMF final transfers from external vendors
• Leads the development and update of established SOPs, WIs, and tools (reference materials, flowcharts, guidelines, checklists, etc.)
• Provides training and mentorship to internal teams and external vendors, as required
• Represents the TMF function at study team meetings, collaborates, and plays an important cross-functional role in TMF document retrieval and management
• Provides support to the Clinical Quality Assurance group during audits and/or regulatory inspections
• Performs investigation of deviations and monitors corrective & preventive actions (CAPA) relating to non-compliance issues and findings
• Establishes and maintains accurate listings for storage of TMF records and routinely verifies continuance of records storage according to corporate policy and regulatory requirements
• Periodically reviews study specific approved TMF indices and collaborates with Clinical Trial Managers to implement updates
• Assists with any additional TMF associated projects, as needed

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Associate’s or Bachelor’s degree preferred
• 2 years of direct experience with electronic TMF system
• Expert knowledge of set-up, maintenance, and transfer of TMFs
• Experience with coordinating document management activities performed by vendors
• Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
• Fundamental knowledge of the conduct of clinical trials is preferred
• Working knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2)
• Excellent organizational skills and attention to detail
• Effective communication and interpersonal skills
• Able to set priorities and juggle multiple demands
• Able to think critically and be a proactive problem-solver
• Able to work independently while exercising initiative, flexibility, and sound judgment
• Ability to operate in alignment with Pliant’s values