Trial Master File Operations Manager
Our Culture: Why Join Us?
At the heart of our success are our people. We thrive on diversity, forward thinking, and unique experiences, all coming together to create a collaborative, supportive, and visionary work environment. United by our passion for making a real difference in the lives of patients and their families, we take immense pride in the vibrant, engaged culture we've built. We think of ourselves as a sports team showing up, supporting each other, and staying committed to our mission while tackling challenges side by side. Our leadership is transparent, approachable, and committed to empowering you every step of the way, At Candel, offering flexibility to help you achieve the perfect work-life balance is part of our culture. With a foundation rooted in 'freedom with accountability,' we trust our team to take ownership of their work, innovate boldly, and make a meaningful impact every day.
Our Science: Transformative treatments for cancer
Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal biological immunotherapies designed to trigger an individualized, systemic anti-tumor immune response. Our two clinical-stage immunotherapy platforms leverage genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively.
This is an exciting time to join Candel as we advance our lead candidate following positive phase 3 results. You will play a pivotal role in driving late-stage workstreams to help bring potentially life-changing products to patients.
Learn more about us at www.candeltx.com
Position Summary:
Manage TMF operations, ensuring quality, inspection readiness, and compliance. Provide study teams with TMF assistance. Develop and optimize TMF management processes, including the TMF Management Plan and Index. Lead TMF Plan and Index development for various studiesWhat you will be responsible for in this role:- As a Trial Master File (TMF) Operations Manager you'll play a pivotal role in managing TMFs for clinical studies. In this role, you will lead the coordination of all documentation ensuring that all documents are accurately collected, organized, and filed in the electronic TMF (eTMF) platform
- Work with multi-functional study teams to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
- Manage user access, user trainings, and set up of all studies from start-up to close-out in system
- Create and maintain study-specific TMF Management Plans.
- Act as the TMF lead for all clinical studies, collaborating across functions
- Ensure compliance with Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, and ALCOA+ principles
- Regularly communicate TMF filing status to ensure alignment with study goals
- Manage and possibly Co-author eTMF Plans, Index, SOPs, SRFs, and guidance documents as the subject matter expert
- Conduct quality control on uploaded documents for accurate indexing and timely uploads
- Establish and monitor quality oversight metrics and KPIs for study TMFs
- Engage with internal teams and CROs/vendors to effectively manage TMF activities
- Conduct study-specific gap analysis reviews and periodic TMF status quality reviews by cross-functional study team and assist with audits and inspections related to TMF activities
- Maintain efficient processes for cataloging, filing, retrieving, and managing TMF records
- Build strong working relationships with vendor(s) to enhance TMF management
- Contribute proactively to eTMF uploads for all relevant clinical studies
Minimum Education, Experience and Skill Requirements:
- Bachelor's degree in biological sciences or a related health field
- 4 -6 years of robust TMF management experience
- Solid understanding of international safety reporting regulations and compliance
- Familiarity with the DIA TMF Reference Model, ICH-GCP, and ALCOA+ standards
- Demonstrated ability to manage TMFs, developing relevant processes and policies
- Strong collaborative skills with an ability to thrive in a fast-paced environment
- Exceptional written and verbal communication, interpersonal, and decision-making skills
- High commitment to excellence and priority on deliverable execution
- Proficient in using an eTMF platform (such as Veeva, Ennov, etc.)
- Oncology experience, in early and/or late-stage studies, is an advantage