Senior TMF Specialist
New
J
JobgetherClinical operations
Based in United States; fully remote position based in CaliforniaContractSenior
Salary40 - 50 USD per hour
Apply NowOpens the employer's application page
Job Details
- Experience
- 5+ years of relevant Trial Master File (TMF) experience.
- Required Skills
- SharePointMicrosoft ExcelPowerPoint
Requirements
- Bachelor’s degree from an accredited institution or equivalent practical experience.
- 5+ years of relevant Trial Master File (TMF) experience.
- Fundamental understanding of filing systems, document management, and organizational tools.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable CFR regulations.
- Familiarity with the CDISC Trial Master File Reference Model structure.
- Experience with Veeva Vault Clinical/eTMF is preferred.
- Proficiency with Microsoft Office applications, particularly Word, Excel, and PowerPoint, and with SharePoint.
- Ability to work independently, manage priorities, and meet deadlines in a remote environment.
- Ability to support audits, inspection readiness, quality reviews, and documentation remediation activities.
Responsibilities
- Upload and maintain clinical trial documents within the Trial Master File system.
- Perform quality control reviews of TMF documents for accuracy, completeness, and adherence to applicable standards.
- Grant and revoke user access according to established TMF processes.
- Prepare and distribute weekly reports to support timely resolution of outstanding quality issues.
- Own periodic TMF Functional QC Review cycles and coordinate follow-up activities.
- Lead TMF completeness checks and keep Expected Document Lists (EDLs) accurate and current.
- Review CRO-owned TMFs and support reconciliation activities.
- Oversee TMF transfers and support archival activities.
- Coordinate with functional content owners, CROs, vendors, and cross-functional stakeholders to maintain documentation standards.
- Participate in audits and support inspection readiness activities.
View Full Description & ApplyYou'll be redirected to the employer's site
