Trial Master File Specialist

ContractTrial Master File SpecialistLocation - Cambridge, MAContract term through end of year with possible extension/ or perm for the right candidateRemote flex -hybrid

2 days in the officePayrate

dependent on exp- very competitiveThis person will be primarily supporting TMF activities from the migration of bringing their TMF in house from the CROVeeva experience an absolute mustBS or equivalent with at least 6 years' experience; must have applicable TMF management experience

Job Title:

ContractTrial Master File SpecialistDepartment:

Clinical Operations

Position Summary:The Contract Trial Master File (TMF) Specialist will assist in and oversee all aspects of TMF Management. The role oversees the collection, quality assessment, processing and archiving of clinical trials documents from both external and internal sources. The TMF Specialist is responsible for ensuring standard service level agreements in relation to TMF Specialist are maintained and supports the definition, implementation, execution and process improvement of TMF Management activities.Duties and Responsibilities:Support and partner with eTMF Business Administrator for account management, create and promote studies in the eTMF and unblinding rulesAct as Subject Matter Expert for eTMF managementEnsure suitable reports and outputs are built to support TMF QualityCreate and support Study Teams in managing the Study TMF Filing planProvide day to day document management supportSupport TMF review process by working closely with study teams, CROs and VendorsEnsure Study EDLs and milestones are aligned on and maintained by study teamsPerform and manage TMF Quality reviews and drive for constant inspection readiness of TMFsServe as point of contact and support study teams for resolution of TMF-related queries or quality issuesAct as point of contact to support TMF audits and inspections as requiredEnsure the CROs portion of the TMF is process in a timely and controlled mannerSupport the management, tracking and quality of TMF migration from CROs eTMF to eTMF systemAuthor, contribute to, maintain and implement TMF management controlled documents and associated resources (e.g. training materials, knowledge databases)Support and/or deliver training across the organization, CRO and Vendors on the policies and procedures relative to and for TMF managementFoster positive relationships with external vendors and internal clinical development areasWork with CRO partners on the continued development of TMF and record management practices and expectationsQualifications:Bachelors Degree or equivalent with significant demonstrable related experience in pharmaceutical/biotechnology industry including records management experience in a GCP-regulated environmentStrong working knowledge of the TMF Reference ModelStrong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMFExperience of electronic document management system(s) and Veeva eTMF preferredWorking knowledge of Regulatory Agency audits and NDA/MAA Submission triggered inspections preferred.Strong interpersonal skill sand ability to manage at all levels within a cross-functional organization through influenceContinuous improvement mindset and ability to function independently with a proactive, self-starter attitudeProficient in common office technology e.g. Microsoft tools, teleconferencing, etc.Ability to handle a high volume of complex tasks with a given timeline

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