Medical Monitor (Oncology)

About the role

PSI, a Contract Research Organization with 30 years of experience in the pharmaceutical industry, is looking for a Medical Monitor (Oncology) to join its international Medical Monitoring team. The role provides medical oversight and expertise across global clinical trials, working with study sponsors, investigators, sites, project teams and other clinical research professionals to protect participant safety and maintain scientific and medical quality.

Key responsibilities

• Serve as the primary medical point of contact for sponsors, internal project teams, investigators and trial sites on medical matters related to the conduct of clinical trials, per protocol and GCP guidelines.
• Provide medical oversight throughout trials in line with the protocol, applicable regulations and ICH-GCP requirements.
• Answer medical questions from investigators, sites, sponsors, project teams and third-party vendors.
• Give medical input on eligibility assessments, protocol deviations, participant safety issues and other trial-specific medical matters.
• Contribute 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.
• Deliver medical and therapeutic area training to investigators and study teams.
• Support medical data review and the assessment of aggregated clinical trial data.
• Take part in bid defense meetings and proposals, pharmacovigilance activities, and advisory or safety monitoring boards.
• Help ensure trial conduct and medical oversight comply with the approved protocol, regulatory requirements and quality standards.

Required profile

• Medical Doctor degree.
• Board certification in Oncology.
• Previous experience as a practicing Oncologist.
• Previous experience in clinical research, the pharmaceutical industry or a CRO is a plus.
• Full professional proficiency in written and spoken English.
• Collaborative, solution-oriented approach to international, cross-functional teams.

Required skills

• Strong medical judgement, analytical thinking and attention to detail.
• Clear communication and presentation skills, able to explain complex medical information to different stakeholders.
• Proficiency in Microsoft Office applications.
• Confidence working with clinical trial systems and digital collaboration tools.