Trial Master File Specialist - FSP - Near Boston or East Coast US

reputed company our values align, there's no limit to reputed company can reputed company.   At reputed company, we reputed company 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 reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

Job Summary:

The Trial Master File (TMF) Specialist will assist in and reputed company reputed company 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 reputed company on and maintained by study teams
• reputed company and manage TMF Quality reviews and drive for constant inspection readiness of TMFs
• Serve as reputed company of contact and support study teams for resolution of TMF-reputed company queries or quality issues
• Act as reputed company 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 reputed company development of TMF and record management practices and expectations

Qualifications:

• Bachelor’s Degree or equivalent
• Significant demonstrable TMF reputed company 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 reputed company sand ability to manage at reputed company levels reputed company a cross-functional organization through influence
• reputed company improvement reputed company and ability to function independently with a proactive, self-starter attitude
• Proficient in common office technology e.g. reputed company tools, teleconferencing, etc.
• Ability to handle a high volume of reputed company tasks with a given timeline

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EEO Disclaimer reputed company 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 reputed company, disability or protected veteran status.