Medical Monitor (Gastroenterology) at PSI CRO

Warsaw, Masovian Voivodeship, Poland -

Full Time

Start Date

Immediate

Expiry Date

23 Jun, 26

Salary

0.0

Posted On

25 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Monitor, Gastroenterology, Clinical Studies, Patient Safety, GCP Guidelines, Protocol Review, Clinical Development Plans, Investigator Brochures, Clinical Study Reports, Safety Data Review, Pharmacovigilance, Risk Mitigation, Advisory Boards, FDA Compliance, EMEA Compliance, ICH Compliance

Industry

Pharmaceutical Manufacturing

Description

Company Description PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. 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: Serve as 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, 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, patient narratives, and scientific presentations Review and analysis of clinical data to ensure the safety of study participants in clinical trials Ensure that the reported trial 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 trial from sites and the study team Provide support for medical data review Participate in bid defense meetings and proposal activities Assist in Pharmacovigilance activities Identify trial risks, and create and implement mitigation strategies with other relevant departments Organize and lead clinical development advisory boards and safety monitoring boards Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines Qualifications Medical Doctor degree Gastroenterology Fellowship certification is a must Prior experience as a practicing MD (minimum of 10 years) Prior research and/or industry experience is a plus Full working proficiency in English Proficiency with MS Office applications Communication, presentation and analytical skills Able to work in teams, problem-solving, 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.

Responsibilities

Medical Monitors serve as the primary medical point of contact for internal teams, sites, and sponsors regarding medical aspects of clinical trials, ensuring adherence to protocols and GCP guidelines. Responsibilities include advising partners on medical matters, collaborating on development plans and regulatory documents, and reviewing clinical data to ensure participant safety.