TMF Lead
Job
Actalent
Remote
$104,000 Salary, Full-Time
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Job Description
Provide TMF and eTMF oversight across assigned clinical studies in a fully outsourced model. Monitor TMF completeness, quality, timeliness, and ALCOA compliance through routine reviews and metrics. Maintain and manage sponsor access to CRO and vendor TMF systems (e.g., Veeva Vault or equivalent). Collaborate with CROs and vendors to ensure proper filing, document QC, and adherence to TMF plans. Support TMF‑related meetings, follow‑ups, action item tracking, and documentation. Identify TMF risks, gaps, and trends; escalate issues and drive remediation with CRO partners. Contribute to audit and inspection readiness activities, including TMF spot checks and document retrieval. Ensure alignment with GCP, regulatory expectations, and internal SOPs. Support continuous improvement of TMF processes, tools, and vendor oversight practices. Additional Skills & Qualifications Experience working in eTMF systems (e.g., Veeva Vault or equivalent) Understanding of GCP and clinical trial documentation requirements Strong attention to detail and comfort managing multiple vendors/studies Ability to support TMF‑related meetings, follow‑ups, and documentation Prior support of audits or inspections preferred Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $40.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in South San Francisco,CA.
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