Trial Master File Expert

Description:

Our client is a young innovative clinical stage Biotech company with a strong development pipeline, now have approval for a new position for a Trial Master File (TMF) Expert within the Clinical Development and Operations group. There is flexibility for this hire to work remotely / from home office, with occasional meetings in their office.

Reporting to the Director of Clinical Development and Operations, this hire will manage TMFs, Sponsor Oversight File (SOF) and Archiving for all studies according to ICH-GCP and other regulatory requirements. This TMF Expert will work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced operational activities.

Additionally, this hire will line manage, coach and develop TMF Specialists. Also, this hire will provide vendor oversight (CROs, etc.) Clinical Study operational activities and present study tracking, progress reporting to CTMs and Leadership team.

Responsibilities for Trial Master File Expert:

Serve as company point of contact for the migration study teams for TMF matters and liaise with the other TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure the migrated TMFs are inspection ready.

Act as company named archivist, responsible for archiving oversight and archiving management, including managing electronic archiving system and coordinating any archiving activities.

Indexing, Post-Migrating Remediation, changing the TMF to e-TMF, Auditing TMF, Meeting Metrics for documentation, doing QC Checks, Archiving.

QC of internal documentation, identifying missing documents and compiling 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, maintaining electronic filing system for all projects for example maintain a tracker of all country insurances.

Manage the ClinTrials.gov and EU Clinical Trials Register.

Work closely with the Clinical Project Managers to organize and execute clinical trial activities.

Liaise with multiple stakeholders, for example investigational site staff 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 and document meeting minutes.

Attend and participate in any company audits or regulatory inspections as required.

Requirements for Lead Trial Master File Expert:

Bachelor of Science degree is preferred.

10+ years’ experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech or CRO industry working ICH / GCP guidelines.

Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines

Experience in QC, maintenance of trial tracking sheets and databases and of preparing documentation for archiving.

Proven ability to work under pressure to meet project deadlines.

Exposure to Veeva Vault and other document management systems, e.g. Docusign, etc.

Excellent communicator of technical and scientific information.

Excellent interpersonal skills, strong organization skills and time management skills.

Strong attention to detail is required.

Proficient in Word, Excel and PowerPoint.