Sr. TMF Specialist - Contract
biomea fusionSan Carlos, CA
$40.00 - $50.00 per hourAPPLY NOW
Sr. TMF Specialist - Contract
biomea fusionSan Carlos, CA
yesterday
Occupations
Document Management SpecialistsBusiness Operations Specialists, All OtherMedical Records SpecialistsIndustries
Research and Development in Biotechnology (except Nanobiotechnology)Custom Computer Programming ServicesOther Computer Related Services$40.00 - $50.00 per hour
APPLY NOWAbout the role
Sr. TMF Specialist Biomea Fusion is hiring a Sr. TMF Specialist, who will be responsible for maintaining the operational aspects of the TMF system and supporting TMF-related activities. This is a contract position for approximately 6 months.
Essential Responsibilities:
- Uploading documents into the TMFPerforming QC of the documents in the TMFGranting/Revoking User Access
- Sending out weekly reports to ensure timely resolution of any outstanding Quality IssuesOwning Periodic TMF Functional QC Review cycles
- Leading Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs)
- Participating in Oversight Reviews of CRO-owned TMFsAssisting in TMF Reconciliations as needed
- Management of TMF activities as needed
- Overseeing the transfer of TMFs as needed
- Supporting the archival of TMFs as needed
- Working directly with functional area content owners as needed
- Participating in audits and assisting with inspection readiness activities as needed
- Partnering with CROs, vendors, and cross-functional groups to ensure adherence to TMF expectations
- Education Requirement:
Bachelor's degree from an accredited institution or equivalent practical experience.
At least 5 years of relevant TMF experience.
Preferred Skills:
- Fundamental understanding of filing systems and organization tools
- Knowledge and understanding of GCP/ICH and CFR Regulations
- Proficiency with Microsoft Office Products - Word, Excel, Powerpoint, Sharepoint
- Familiarity with the CDISC Trial Master File Reference Model structure
- Experience with Veeva Vault Clinical (eTMF)
- Ability to work independently and prioritize tasks
Compensation:
The expected compensation rate is $40 to $50 per hour, dependent on experience and location.
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JOB OVERVIEW
Salary
$40.00 - $50.00 per hour
Experience level
Senior
Location
San Carlos, CA
Occupation
Document Management Specialists
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
yesterday
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