Job 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 Lead Trial Master File (TMF) Specialist within the Clinical Development and Operations group. There is flexibility for this hire to work remotely / from home office, with occasional meetings in their Dublin office.
Reporting to the Director of Clinical Development and Operations, this hire will support several Clinical Study Managers across Phase I-III trials, covering multiple responsibilities of outsourced operational activities to all applicable regulatory guidelines.
Additionally, this hire will coach and develop more junior team members in TMF and Clinical Study operational activities.
Responsibilities for Lead 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 eTMF, 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 Lead Trial Master File Specialist:
Bachelor of Science degree is preferred.
5+ 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 / larry@rftgroup.ie
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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