Trial Master File Specialist
|Contact Name:||Larry O’Leary|
Our client is a young innovative clinical stage biopharmaceutical company with a strong development pipeline, now have approval for a new position for Trial Master File (TMF) Specialist within the Clinical Operations team based in Dublin.
You will be part of a small and collaborative team which prides itself in producing high-quality work, while working in a fast-paced environment. Most of the time this hire will work remotely / from home office, with a few days per month in their Dublin office.
Supporting Clinical Operations activities and Clinical Study Managers, this hire will have multiple responsibilities across the company Clinical Trials working to ICH / GCP guidelines.50% of the role will be based on reviewing and QC’ing TMFs held by our CROs.
This fast-growing Biopharma company will have opportunity for this hire to progress within Clinical Operations roles, supporting oversight and management of vendor activities.
Responsibilities for Trial Master File Specialist:
Serve as 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
Indexing, Post-Migrating Remediation, changing the TMF to e-TMF, Auditing TMF, Meeting Metrics for documentation, doing QC Checks, Archiving
QC of 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 Study 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
Requirements for Trial Master File Specialist:
Bachelor of Science degree is preferred.
2+ years’ experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech or CRO industry working ICH / GCP 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.
Experience in both paper and electronic and familiarity with naming and filing conventions, including experience with either: Docusign, Veeva Vault, 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.
Please contact Larry on +353 1 – 2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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