Oferty pracy: medical affairs

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.

PSI is seeking a Medical Monitor (Oncology) to join our international Medical Monitoring team.

In this role, you will provide medical oversight and expertise across global clinical trials, working closely with study sponsors, investigators, sites, project teams, and other clinical research professionals. Your contribution will help protect participant safety, maintain scientific and medical quality, and support the successful delivery of oncology studies.

This is an opportunity to apply your clinical oncology experience to international research and contribute directly to the development of new treatments for patients who need them.

Full-time employment

Responsibilities:

• Serve as primary medical point of contact for clinical trial sponsors, internal project teams, investigators and trial sites for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines
• Provide medical oversight throughout the conduct of clinical trials, in accordance with the protocol, applicable regulations, and ICH-GCP requirements
• Respond to medical questions from investigators, sites, sponsors, project teams, and third-party vendors
• Provide medical input into eligibility assessments, protocol deviations, participant safety issues, and other trial-specific medical matters
• Contribute medical expertise to clinical development plans, protocols, investigator brochures, informed consent documents, annual reports, clinical study reports, patient narratives, and scientific presentations
• Review and assess clinical and safety data to support participant safety and identify medically relevant trends, risks, or quality concerns
• Prepares and delivers medical training and/therapeutic area training to investigators and study teams
• Support medical data review activities and contribute to the assessment of aggregated clinical trial data
• Participate in bid defense meetings and proposal activities
• Provide support with Pharmacovigilance activities
• Identify medical trial risks, and collaborate with relevant functions to define appropriate mitigation and escalation measures
• Support or participate in advisory boards, safety monitoring boards, and other medical or scientific committees, as applicable.
• Help ensure that trial conduct and medical oversight activities comply with the approved protocol, applicable regulatory requirements, and quality standards

You will be a strong fit for this role if you have

• Medical Doctor degree
• Board certification in Oncology
• Previous experience as a practicing Oncologist
• Previous experience in clinical research or the pharmaceutical or CRO industry is a plus
• Full professional proficiency in written and spoken English
• Strong medical judgement, analytical thinking, and attention to detail
• Clear communication and presentation skills, with the ability to explain complex medical information to different stakeholders
• A collaborative and solution-oriented approach to working within international, cross-functional teams.
• Proficiency in Microsoft Office applications and confidence working with clinical trial systems and digital collaboration tools.

As part of PSI's Medical Monitoring team, you will become part of an international team of medical professionals working at the frontline of clinical research. You will have the opportunity to apply your oncology expertise across global studies, collaborate with experienced colleagues, and contribute to bringing new treatment options to patients.