TMF Document Specialist

Company Profile:

At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan.

We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation.

TMF Document Management & Oversight

• Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements.
• Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible.
• Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management.
• Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks.
• Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed.
• Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries.
• Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible.
• Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment.

Project Team Support

• Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle.
• Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index.
• Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model.
• Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations.

TMF Metrics & Reporting

• Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement.
• Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes.
• Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings.

Inspection Readiness

• Ensure the TMF complies with all applicable regulatory requirements and guidelines.
• Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation.
• Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization.

Qualifications

• Bachelor’s Degree Required.
• 3 years of hands-on Veeva Vault eTMF experience required.
• 5 years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable.
• TMF Certification or TMF training optional but preferred (e.g., DIA’s TMF Certificate Program. LMK TMF University) or other relevant certifications.

Key Skills, Abilities, and Competencies

• Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.).
• Experience in managing TMF documents during audits or regulatory inspections.
• Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA standards, and regulatory requirements.
• Basic understanding of study and site management and overall trial planning and execution.
• Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations.
• Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint.

Core Competencies

• Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines.
• Strong work ethic, organizational skills, oral and written communication skills, a ‘can do’ approach, problem-solving skills, and team player skills.
• Ability to multi-task and manage several projects in parallel while paying attention to detail.
• Strong critical thinking skills and ability to contribute creative yet practical solutions to problems.

The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.