Clinical Document Control / TMF Specialist
Location:
Galway City - full time onsite
Duration:
Full Time Permanent
Industry:
Medical Device Start-up
Ideal Experience Required:
3 years in similar role
About
My client are looking for a
Document Control/TMF Specialist
to play a key role in supporting the execution of pivotal clinical trials by managing essential study documentation. Working closely with the Senior Clinical Research Associate and Director of Clinical Operations, you will be the main point of contact in ensuring clinical trial documentation is up to date and compliant with GCP.
This is an important hire within the Clinical Operations Department, at a rapidly growing startup. You will have an opportunity to contribute to the start-up, execution, and close-out of key pivotal clinical trials.
What You Will Do:
* Manage and maintain study documents in alignment with sponsor requirements, study-specific processes, and company SOPs.
* Collaborate closely with clinical study teams to support documentation needs and ensure timely completion of TMF activities.
* Perform document processing tasks including receipt, review, scanning, indexing, quality control, filing, and archiving.
* Support departmental projects and initiatives, ensuring timely and accurate completion.
* Provide updates and data for departmental status reports as needed.
* Escalate training needs, project updates, quality concerns, and timeline risks to the clinical team
Personal Attributes – The Ideal Candidate Is:
* Communicative:
Proficient in written and verbal communication and collaboration skills. You are able to identify appropriate communication channels for problems and concerns.
* Self-Driven:
You have a sense of urgency in your work and thrive when taking responsibility for tasks. Proactive thinker and problem-solver with an enthusiasm to learn new concepts and a growth mindset.
* Attention to Detail:
Understands and adheres to company policies and procedures. Understands and adheres to all external standards, and applicable regulations. Ability to work under strict guidelines, competing priorities, and immediate requests.
* Professional:
Displays a neat, clean, and professional appearance at all times.
Requirements – The Ideal Candidate Must Have:
* Bachelor's degree in Life Sciences or a related field.
* 1–3 years
of hands-on experience with Trial Master File (TMF) management in a clinical research setting.
* Strong understanding of good clinical practice (GCP), clinical study documentation, and regulatory requirements.
Advantages – It Would be Advantageous to Have:
* Prior experience within the medical device industry and start-ups
* Proficiency in utilising Electronic Data Capture (EDC) systems
* Ability to learn and become competent with company used computer, telephone, and EDCs, where applicable
For more information, contact Alan on