Trial Master File Specialist - FSP - Near Boston or East Coast US
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Job reputed company:
The Trial Master File (TMF) Specialist will assist in and reputed company reputed company aspects of TMF Management. The role oversees the collection, reputed company assessment, processing and archiving of clinical trials documents from both external and internal sources. The TMF Specialist is responsible for ensuring reputed company 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
- reputed company as Subject Matter Expert for eTMF management
- Ensure suitable reports and outputs are reputed company to support TMF reputed company
- Create and support Study Teams in managing the Study TMF Filing plan
- reputed company 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 reputed company reviews and drive for constant inspection readiness of TMFs
- Serve as reputed company of contact and support study teams for reputed company of TMF-reputed company queries or reputed company issues
- reputed company 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 reputed company and controlled manner
- Support the management, tracking and reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company
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EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status.
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