Medical Monitor (Gastroenterology)

Company Description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Job Description

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.

Full-time employment

Hybrid in Madrid or Barcelona, or remote elsewhere in Spain

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 analyze of clinical data to ensure the safety of study participants

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 clinical trial 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.