Trial Master File & Start Up Lead

Flatiron Health; North East; Hybrid; GBP 80,000 - 100,000; Full time

Job description

Reimagine the infrastructure of cancer care within a technology and science community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem. We're looking for a Trial Master File & Start Up Lead to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Are you ready to be the next changemaker in cancer care?

What You'll Do

Flatiron is building a rapidly growing business that is already accelerating oncology R&D and filling an unmet need in cancer research. By designing pragmatic, fit-for-purpose clinical trials that can run nearly in the background of routine oncology care, we’re leveraging Flatiron’s next generation technology and trial services to close evidence gaps. You will lead the Trial Master File (TMF) process, ensuring that all essential documentation is in place and compliant with regulatory requirements. Additionally, you will oversee the site start-up activities for clinical studies.

In this role, you will:

1. Collaborate with a variety of internal stakeholders to ensure that all aspects of trial start-up and TMF management are executed with precision and efficiency and on time.
2. Lead the Trial Master File (TMF) process, ensuring that all required documents are collected, reviewed, and maintained in compliance with regulatory standards.
3. Oversee the start-up process for clinical trials, including collection and review of site regulatory documents, and regulatory submissions.
4. Partner with cross-functional teams to ensure smooth trial start-up and timely activation of clinical sites.
5. Drive continuous improvement by identifying bottlenecks and inefficiencies in the start-up process and making recommendations for streamlined workflows.
6. Act as the primary point of contact throughout the start-up phase of the trial, ensuring clear communication and timely responses to inquiries.
7. Provide expertise and guidance to internal teams on TMF best practices, regulatory requirements, and trial start-up processes.

Who You Are

You are skilled in project management and thrive in managing multiple tasks and stakeholders with competing priorities. You are highly organized and detail oriented with a passion for ensuring clinical trials run efficiently and are fully compliant with regulatory standards. You are comfortable working in fast-paced, evolving environments and can adapt to changing priorities quickly.

1. At least 2 years of work experience in trial start-up, TMF management, or clinical operations, ideally within the pharmaceutical, CRO, or oncology research field.
2. Strong understanding of regulatory requirements, GxP compliance, and clinical trial documentation standards.
3. Demonstrated ability to manage multiple projects and coordinate cross-functional teams.
4. Excellent organizational skills and attention to detail.
5. Ability to manage competing priorities and work under pressure to meet deadlines.
6. Bachelor’s degree or equivalent experience in a relevant field.
7. Experience working with clinical trial management systems (CTMS) and TMF systems.
8. A passion for improving cancer care and accelerating oncology research.

Where you’ll work

In this hybrid role, you’ll have a defined work location that includes work from home and 3 office days set by you and your team. For more information on our approach to hybrid work, please visit the how we work website.