Job Description
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
Responsibilities:
1. Advise clients, project teams, sites, regulatory agencies and third-party vendors on medical matters
2. Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
3. Review and analysis of clinical data to ensure the safety of study participants in clinical studies
4. Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
5. Address safety issues across the study from sites and the study team
6. Provide support to medical data review
7. Participate in bid defense meetings and proposal activities
8. Assist in Pharmacovigilance activities
9. Identify trial risks, and create and implement mitigation strategies together with other relevant departments
10. Ability to organize and lead clinical development advisory boards and safety monitoring boards
11. Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
Qualifications
12. Medical Doctor degree
13. Infectious Diseases Fellowship certification is a must
14. Prior and wide experience as a practicing MD (minimum of 10 years)
15. Full working proficiency in English
16. Proficiency with MS Office applications
17. Communication, presentation and analytical skills
18. Problem-solving, team and detail-oriented