Instagram
youtube
Facebook
2+ years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

TMF Associate
Location: San Francisco, CA
Job Category: Contract


About the Role
Our client is seeking a Contract Trial Master File (TMF) Associate to support high-quality TMFs across ongoing and completed clinical studies, ensuring adherence to ICH-GCP guidelines, other regulatory requirements, and SOPs. This is a 6-month contract role based in South San Francisco with a hybrid schedule (4 days in the office, 1 day remote).


Key Responsibilities

  • Contribute to the development and management of paper and electronic TMF systems for clinical trials, ensuring completeness, accuracy, and regulatory compliance

  • Upload study documents into various eTMF platforms (e.g., Veeva)

  • Reconcile and conduct quality control (QC) for eTMF uploads

  • Ensure timely and accurate filing of essential documents per regulatory requirements and company SOPs

  • Collaborate with Study Teams to ensure the effective implementation of TMF Management Plans

  • Assist in the creation, maintenance, and tracking of TMFs for each assigned study

  • Perform regular reviews and quality checks of TMFs to ensure completeness, accuracy, timeliness, and consistency

  • Manage the transfer of study-specific TMF to designated parties

  • Act as a point of contact for Study Team TMF questions and address any discrepancies or missing documents

  • Support the close-out of TMF-related issues

  • Collaborate with cross-functional teams to ensure timely submission and retrieval of documents

  • Aid in the identification and resolution of documentation issues

  • Educate and support Study Teams on TMF-related responsibilities

  • Identify process improvement opportunities for TMF management and assist in updating SOPs, WIs, and training materials

  • Prepare and support TMF-related audits and inspections by regulatory authorities


Qualifications

  • Bachelor's degree required

  • 2 years of TMF experience

  • Sponsor experience required

  • Veeva Vault experience preferred

  • Familiarity with regulatory requirements (ICH, GCP, FDA) for clinical trials

  • Experience with electronic Trial Master File systems and document management preferred

  • Proficient in MS Office applications (Word, Excel, Outlook)

  • Excellent organizational, communication, and problem-solving skills

  • Strong attention to detail with the ability to manage multiple tasks and prioritize effectively

  • Collaborative team player with the ability to educate and interact positively with diverse teams


Additional Information
CRN, a division of Solomon Page, provides a comprehensive benefits program, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits for hourly employees, including consultants.