Job Description The CTM role will involve regional management on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region. The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. The candidate will likely work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. The successful candidate will have the ability to work successfully with cross-functional team members globally and to manage stakeholders accordingly. Specific Responsibilities
1. Works with Clinical Program Managers to manage regional component of Virology clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes
2. Interacts with cross-functional teams internally and externally to ensure trial progress
3. Incorporate study logistics and planning to accomplish study objectives
4. Serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems
Knowledge, Experience and Skills
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5. Significant relevant experience and a BSc or nursing qualification in a relevant scientific discipline
6. Previous experience in Virology areas would be advantageous but not essential
7. Previous study management/coordination experience at Sr CTMA level
8. Monitoring experience is highly desirable as co-monitoring will be required
9. Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
10. Must have a general, functional expertise to support SOP development and implementation
11. Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
12. Excellent teamwork, decision-making and organizational skills are key to success
13. Strong communication skills
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