Your new company
Here, in Hays Life Sciences, our Multinational Clinical Trials client in Dublin is hiring a Clinical Trials Manager. The Clinical Trials Manager will be a valued member of the Clinical Operations team. They will work with the Clinical Program Manager and study teams to manage global clinical trials or regional components of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
Key Responsibilities:
1. Manage global studies and/or regional components of global Phases II-III outsourced studies managed by a Clinical Program Manager.
2. Independently manage all components of a small, less complex clinical study.
3. Manage cross-functional timelines and maintain the study timelines.
4. Contribute to the development of the study budget.
5. Manage vendors, including CROs.
6. Serve as the primary point of contact for CROs, addressing questions and applying knowledge to solve problems.
7. Assist in determining the activities to support a project’s priorities within a functional area.
8. Draft and coordinate review of relevant documents including protocols, Informed Consents, Case Report Forms, monitoring plans, Investigator Brochures and Clinical Study Reports.
9. Understand, interpret and explain protocol requirements to others.
10. Coordinate review of data listings and preparation of interim/final Clinical Study Reports.
11. Contribute to the development of RFPs and participate in the selection of CROs/vendors.
12. In collaboration with data management, develop and participate in review of clinical study data and other metrics to ensure data integrity.
13. File necessary documents in the electronic trial master file (TMF), and provide oversight for regular cross-functional reviews of the TMF.
14. Train CROs, vendors, investigators and study coordinators on study requirements.
15. Serve as a resource for others within the company for clinical trials management expertise.
16. Participate in departmental or interdepartmental strategic initiatives under limited supervision.
17. Contribute to development of abstracts, presentations and manuscripts.
18. Support the professional development and mentoring of Clinical Trial Manager Associates.
19. Conduct oversight monitoring visits, as required.
20. Travel is required.
Education and/or Experience:
1. B.Sc. or BA in a relevant scientific discipline or RN qualification.
2. At least five years of relevant clinical trial experience in the pharmaceutical industry.
3. Demonstrates an ability to manage studies or programs of higher complexity from both processes and strategic perspective.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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