TMF Specialist

We are seeking a highly skilled TMF Specialist to join our team at Beacon Hill Life Sciences - Boston. As a key member of our clinical trials management team, you will be responsible for overseeing all aspects of TMF Management, ensuring standard service level agreements are maintained, and supporting the definition, implementation, execution, and process improvement of TMF Management activities.

• TMF Management: Assist in and oversee all aspects of TMF Management, including collection, quality assessment, processing, and archiving of clinical trials documents from both external and internal sources.
• eTMF Management: Support and partner with eTMF Business Administrator for account management, create and promote studies in the eTMF, and unblinding rules.
• Subject Matter Expert: Act as Subject Matter Expert for eTMF management, ensuring suitable reports and outputs are built to support TMF Quality.
• Study Team Support: Create and support Study Teams in managing the Study TMF Filing plan, provide day-to-day document management support, and ensure Study EDLs and milestones are aligned and maintained by study teams.
• TMF Quality Reviews: Perform and manage TMF Quality reviews, drive for constant inspection readiness of TMFs, and serve as a point of contact and support study teams for resolution of TMF-related queries or quality issues.
• TMF Audits and Inspections: Act as a point of contact to support TMF audits and inspections as required, ensuring the CRO's portion of the TMF is processed in a timely and controlled manner.
• TMF Migration: Support the management, tracking, and quality of TMF migration from CROs eTMF to eTMF system.
• Training and Development: Author, contribute to, maintain, and implement TMF management controlled documents and associated resources, and support and/or deliver training across the organization, CRO, and Vendors on the policies and procedures relative to and for TMF management.
• Vendor Management: Foster positive relationships with external vendors and internal clinical development areas, and work with CRO partners on the continued development of TMF and record management practices and expectations.

• Education: Bachelor's Degree or equivalent with 6+ years significant demonstrable related experience in pharmaceutical/biotechnology industry including records management experience in a GCP-regulated environment.
• Knowledge and Skills: Strong working knowledge of the TMF Reference Model, 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.
• Interpersonal Skills: Strong interpersonal skills and ability to manage at all levels within a cross-functional organization through influence.
• Continuous Improvement: Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude.
• Technical Skills: Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
• Time Management: Ability to handle a high volume of complex tasks with a given timeline.