Trial Master File Specialist - FSP - Near Boston or East Coast US
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The 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. Key Accountabilities: Support and partner with eTMF Business Administrator for account management, create and promote studies in the eTMF and unblinding rules Act as Subject Matter Expert for eTMF management Ensure suitable reports and outputs are built to support TMF Quality Create and support Study Teams in managing the Study TMF Filing plan 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 aligned on and maintained by study teams 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 Ensure the CRO’s portion of the TMF is process in a timely and controlled manner Support the management, tracking and quality of TMF migration from CROs eTMF to eTMF system 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 the organization, 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 CRO partners on the continued development of TMF and record management practices and expectations Qualifications: Bachelor’s Degree or equivalent Significant demonstrable TMF lead experience in pharmaceutical/biotechnology industry including records management experience in a GCP-regulated environment 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 skill sand 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 with a given timeline #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.