Klinischer monitor Jobs in Neubiberg

PSI Medical Monitors  provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and wellbeing.

Responsibilities :

• 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 thirdparty 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 :

Additional Information :

As part of PSIs 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.

Remote Work : Employment Type :

Fulltime

Key Skills

Hospital Experience,Acute Care,Basic Life Support,ICU Experience,Infusion Experience,Triage,TFS,Conflict Management,Nursing,Critical Care Experience,Epic,Medication Administration

Experience : years

Vacancy : 1