Job Description
We are seeking a highly experienced Trial Master File (TMF) Expert to join our Clinical Development and Operations team. As a TMF Expert, you will play a critical role in ensuring the quality and integrity of our clinical trial data.
You will be responsible for managing TMFs, Sponsor Oversight Files (SOF), and archiving for all studies according to ICH-GCP and other regulatory requirements. This includes working closely with Clinical Project Managers across Phase I-III trials, overseeing outsourced operational activities, and providing vendor oversight.
In addition, you will line manage, coach, and develop TMF Specialists. Your expertise will also extend to presenting study tracking and progress reporting to CPMs and the Leadership team.
Responsibilities:
* Act as the company point of contact for migration study teams for TMF matters, liaising with other TMF Subject Matter Experts (SMEs) and process owners to ensure migrated TMFs are inspection-ready.
* Manage electronic archiving systems and coordinate archiving activities, serving as the company named archivist.
* Indexing, post-migrating remediation, changing TMF to e-TMF, auditing TMF, meeting metrics for documentation, doing QC checks, and archiving.
* QC internal documentation, identify missing documents, and compile tracking sheets in accordance with agreed processes.
* Support project teams through (e)TMF and study document management, vendor management, assist with regulatory and ethics submissions.
* Support key project management tasks, including creation of project-specific oversight plans, setting up project tracking tools, and maintaining electronic filing systems.
* Manage ClinTrials.gov and EU Clinical Trials Register.
* Work closely with Clinical Project Managers to organize and execute clinical trial activities.
* Liaise with multiple stakeholders regarding end-of-trial archiving requirements.
* Schedule meetings and manage travel arrangements.
* Participate in team meetings, including cross-functional team meetings and meetings with third-party vendors.
Requirements:
* Bachelor of Science degree preferred.
* 10+ years' experience managing TMFs in Clinical Operations environments, with ICH/GCP guidelines knowledge.
* Experience in both paper and electronic TMFs, familiarity with naming and filing conventions, CDISC TMF Reference Model, and applicable industry guidelines.
* Proven ability to work under pressure to meet project deadlines.
* Exposure to Veeva Vault and other document management systems, excellent communicator of technical and scientific information.
* Excellent interpersonal skills, strong organization skills, and time management skills.