Trial Master File (TMF) Specialist Oncology
About The Position
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
Requirements
- BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
- Knowledge of and direct experience with Trial Master Files.
- Prior eTMF (e.g. Veeva) administration required.
- Strong Microsoft Office skills required.
- Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
- Strong focus on teamwork, attention to detail, excellent organizational skills.
- Must have ability to prioritize, and the ability to work in a multi-task environment.
Nice To Haves
- Fundamental knowledge of the conduct of clinical trials is preferred.
Responsibilities
- Responsible for overall quality, maintenance, and completeness of Trial Master Files.
- Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
- Develop project specific TMF plan and structure and update the plan as needed.
- Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
- Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
- Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
- Provide study team reports or updates regarding status of TMF on a regular basis.
- Participate in audits and provide documents as requested.
- Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
- Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
- Champion best practices for building and maintaining TMF health.
Benefits
- opportunity for merit-based salary increases
- short incentive plan participation
- eligibility for our 401(k) plan
- medical, dental, vision, life and disability insurances and leaves provided in line with your work state
- flexible paid time off
- 11 paid holidays plus additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
