Medical Monitor

About the Company

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.

Location: Full-time employment based in Bangkok

Responsibilities

• Advise clients, project teams, sites, data safety monitoring boards, 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, manuscripts, and scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure 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
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify program risks, and create and implement mitigation strategies with Clinical Operations
• Organise and lead clinical development advisory boards and safety monitoring boards
• Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance

Qualifications

• Medical Doctor degree
• Board-certification in a major therapeutic area (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine) is desirable
• Prior experience in Clinical Research
• Familiarity with clinical concepts, practices and local regulations regarding clinical research trials; experience with local health authority interactions leading to drug approval strongly preferred
• Ability to interact with and train clinical monitors and physician investigators and build constructive, trusting and respectful relationships with colleagues at all levels
• Excellent leadership, communication, presentation, and organizational skills with sound critical thinking and problem-solving abilities and the ability to execute responsibilities with minimal guidance
• Proficiency with MS Office applications

Additional Information

Join our highly dedicated team of clinical research professionals with 250+ Medical Doctors onboard, and make a tangible difference within a professional and energetic organization founded by scientists.