Beacon Hill · 2 days ago
Remote - Trial Master File (TMF) Specialist
United States
Contract
Remote
Mid Level
$45/hr - $50/hr
4+ years expBeacon Hill is a highly reputable biotechnology corporation and they are seeking a Trial Master File (TMF) Specialist to work remotely in the United States. The TMF Specialist will support TMF-related activities and manage documentation of files with CROs and TMF vendors while ensuring TMF quality and compliance throughout the lifecycle of clinical studies.
Staffing Agency
Hiring Manager
Andrew Osborn
Responsibilities
The TMF Specialist will support TMF-related activities in collaboration with the internal cross functions and manage documentation of files with CROs and TMF vendors according to study TMF plans
Accountable for the management of paper and electronic trial master files across clinical studies
Assist in the in-house TMF Operations to support Clinical Development
Collaborate with clinical study teams to manage study TMF plans and indexes with CRO partners and TMF vendor
Partner with cross-functions to ensure TMF quality, timeliness, and completeness throughout the lifecycle of the studies
Maintain TMF configurations, processes, procedures, and training materials that adhere to regulatory requirements
Manage the quality control of TMF documents according to GCP and regulatory requirements from study start up to study closeout/archival and preparation for inspections
Collaborate with clinical study teams to monitor TMF inventory lists, metrics, periodic TMF reviews according to study specific TMF plan, oversee KPIs, identify areas for improvements and develop change processes, as needed
Serve as eTMF business administrator, including monitoring the impact of configuration changes to optimize performance
Support TMF elements of regulatory inspections in providing relevant documents and responses, as needed
Qualification
Required
Bachelors in Life Sciences or advanced degree
A minimum of 4 years of experience maintaining eTMF system(s)
Must have experience with Veeva Vault system (eg, eTMF)
Understanding and experience with TMF reference model and cross-functional clinical processes
Excellent planning, organizational, and time management skills to support and prioritize multiple projects
Must be self-motivated, able to evaluate and resolve complex problems, and adaptable to a dynamic fast-paced environment
Expertise in quality and GCP requirements to ensure the organization remains compliant with ICH GCP and other global regulatory guidelines or laws
Excellent written and verbal skills required
Preferred
Prior inspection readiness experience is highly desired
Company
Beacon Hill
Beacon Hill was founded to set a new standard in search, career placement and flexible staffing.
1001-5000 employees
H1B Sponsorship
Beacon Hill has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (94)
2023 (76)
2022 (60)
2021 (77)
2020 (86)
Funding
Current Stage
Late StageLeadership Team
Amber Leslie
Executive Assistant to CEO
Amy Van Sicklin
Chief Culture Officer
Recent News
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