Mundipharma
R&D Document Specialist
Location: Cambridge - Hybrid/Remote
Job Type: FTC
Department: Clinical Operations
Join us and make a difference when it matters most!
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The team
Provide support to Clinical Project Managers (CPMs) and other functions within R&D to ensure GCP compliant documentation is maintained and undertake specific delegated responsibilities in the management and conduct of clinical trials to ensure delivery of trials to GCP, in accordance with project plans and budget.
Role and Responsibilities
1. Undertake tasks within clinical trial management and archiving according to MRL SOPs. Provide support services across multiple projects and therapeutic areas.
2. Oversee the collection, review, and archiving of essential trial documents in the electronic Trial Master File (eTMF) to ensure completeness and compliance.
3. Includes emails, draft docs with comments, Sponsor approvals.
4. Periodically review the eTMF to ensure accuracy and regulatory compliance.
5. Perform Sponsor oversight activities for CRO/MRL eTMF.
6. Conduct quality checks e.g. check documentation is correctly filed, identify missing information.
7. Raise queries with CROs and carry through to resolution.
8. Internal process related support.
9. Create, update and maintain clinical trial trackers.
10. Collate and maintain study team related information e.g. confirmation of training, annual leave, etc.
11. Complete administrative documentation e.g. Clinical trial agreement (CTA) checklists, trackers, taking minutes/actions of team meetings.
12. Support the team with document review.
13. Support R&D team in maintaining a state of continuous inspection readiness.
14. Coordinate and participate in the preparation and conduct of TMF audits and GCP inspections.
What You’ll Bring
1. BSc or equivalent.
2. Robust knowledge of the clinical trial process.
3. Experience working with Veeva Vault and/or Phlex TMFs.
What We Offer in Return
1. Flexible benefits package.
2. Opportunities for learning & development through our varied programme.
3. Collaborative, inclusive work environment.
Diversity and Inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
About Mundipharma
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.
Join our talent pool
If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
Additional Job Description:
Primary Location: GB Cambridge
Job Posting Date: 2025-01-02
Job Type: Fixed Term Contract (Fixed Term)
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