We are seeking a Trial Master File Specialist (TMF Specialist) to join the clinical operations team. In this newly created position, you will be responsible for the day-to-day management of TMF files for their respective studies, including the upload, review, and approval of TMF documents. This role will ensure that study documents are performed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and to ensure their assigned studies are inspection-ready.

Key Responsibilities

• Will conduct quality reviews of essential documents using the established TMF specifications, ICH-GCP guidelines, ALCOA , regulatory requirements, and applicable SOPs.
• Review and maintain study-specific TMF plans, TMF indices, and EDLs for their respective studies, working both cross-functionally and with CROs.
• Conduct completeness reviews and remediating post-review findings of TMF QC along with query management and providing best practice recommendations to the functional teams.
• Perform document upload, classification, and indexing in the eTMF system.
• Assist with inspection/audit-related activities (e.g., preparation, correction action plans).
• Maintain up-to-date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements.
• Attend study meetings and provide updates or reminders surrounding TMF activities e.g. communicating issue trends or process change.
• Perform other duties as assigned such as reviewing TMF guidance documents, training, and building TMF content, and supporting the TMF team in various activities.

Ideal Candidate

• Minimum B.A./B.S. degree in science/healthcare field
• 5 years of overall relevant clinical operations and TMF experience at a biotechnology, pharmaceutical, or TMF vendor, including:
• 3 years of experience working for a CRO supporting Clinical Operations
• 3 years of experience working in eTMF system software; experience in Veeva Vault eTMF system is highly preferred.
• Must be fully proficient in MS Office Suite, and familiar with Smartsheet and SharePoint.
• Understanding of the clinical trial lifecycle.
• Experience in handling clinical trial-related documents required.
• Strong knowledge of Trial Master File Reference Model Structure standards
• Demonstrated ability to understand and comply with ALCOA standards, ICH-GCP guidelines, and Good Documentation Practices
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment.
• Willingness to travel up to 10% including a minimum of 4 times per year for All Hands company meetings.
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Strong organization skills with outstanding attention to detail and follow-through
• Demonstrated effective communication skills with internal and external team members, highly conscientious.
• Must be resourceful and adaptable to effectively support multiple competing demands and changing priorities.
• Demonstrated proactive approaches to problem-solving with strong decision-making capabilities.

The anticipated salary range for candidates for this role will be $120,000-$140,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.