[Hiring] Medical Monitor @PSI CRO
Apr 07, 2025 - PSI CRO is hiring a remote Medical Monitor. đź’¸ Salary: unspecified. đź“ŤLocation: Europe.
Role 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.
- Medical point of contact for internal project team, study sites and study sponsor for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, narratives, and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- 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
- Address safety issues across the study from sites and the study team
- Supports and/or performs medical data review of the operational clinical trial database
- Participate in meetings with clients and Investigators
- Assist in Pharmacovigilance activities
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical medically relevant documents.
Qualifications
- Medical Doctor degree
- Oncology Fellowship certification is a must
- Prior and wide experience as a practicing Oncologist (minimum of 10 years)
- Full working proficiency in English
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
Additional Information
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
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| đź“Ť | Be aware of the location restriction for this remote position: Europe |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
đź’¸
unspecified
|
Remote
Location
Europe
|
|
Job Type
full-time
|
Posted
Apr 07, 2025
|
| đź“Ť | Be aware of the location restriction for this remote position: Europe |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
