Manager, Trial Master File (eTMF) Operations

At Aditum Bio our mission is to give patients access to medicines that may not otherwise be developed. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic.  The firm focuses on the translational phase of medicine (Phase I and Phase II) to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

The Manager, Trial Master File (eTMF) Operations is primarily responsible for eTMF operations and GCP/quality document management, as aligned with study requirements, SOPs and ICH-GCP guidelines. This includes the maintenance of eTMF structures across multiple Aditum Bio programs, review and approval of eTMF documents, interacting with the Study Teams and the Investigational Sites to maintain current eTMF documents, as well as producing reports to ensure accuracy and timeliness. To ensure eTMFs are always inspection-ready, the eTMF Manager will hold themselves and others accountable to high-quality and complete documentation. The eTMF Manager will collaborate effectively and proactively with key stakeholders in Aditum Bio’s Clinical Operations, Quality and Regulatory functions.  The Manager may also be called on to support other functional areas to support other activities including but not limited to maintaining Study Team training records, drafting and updating Aditum Bio and affiliates’ SOPs, creating Work Instructions and drafting study Notes-to-File.

• Primarily responsible for eTMF management and oversight for Aditum Bio’s clinical trials
• Develop and adhere to inspection readiness goals, working closely with study team members to ensure progress
• Generate reports to monitor eTMF health and document expiry, ensuring quality, accuracy, completeness and timeliness
• Communicate and document issues or inconsistencies to relevant functional leads
• In collaboration with Quality Assurance, maintain a schedule for internal eTMF audits and draft Annual Audit Plans
• Support regulatory inspections and audits
• Apply working knowledge of ICH/GCP guidelines to eTMF management activities
• Maintain close and productive working relationship with peers and leaders in Clinical Operations, Quality Assurance and Regulatory as well as key external partners (e.g. CRO)
• Assist other functional areas with SOP management, training record maintenance and the drafting of various clinical trial-related documents.

• Associates or bachelor’s degree in life sciences or healthcare related field of study
• Minimum 5 years of clinical research experience, with some experience in small biotech
• Demonstrated expertise with eTMF systems (e.g. Trial Interactive)
• Working knowledge of drug development and clinical research processes, with an applied understanding of regulatory requirements and GCP guidelines
• Highly organized individual to ensure documentation is easily accessible, up to date and arranged simply
• Keen attention to detail with an ability to balance efficiency with high-quality work
• Ability to work and prioritize independently, while knowing when to escalate matters to management
• Strong communication skills and demonstrated ability to tailor written and verbal messaging to audiences spanning senior leadership, external vendors, and peers
• Ability to problem solve collaboratively and establish a trusting, positive relationship with colleagues