Medical Monitor (Gastroenterology)

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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 based in Malaysia

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 different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the 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
• Ability to 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 Gastroenterology is preferred
• Clinical experience in major therapeutic area (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine) is desirable 
• Prior experience in Clinical Research.
• Full proficiency in English (written and spoken)
• Familiar and comfortable 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 within and outside the organization
• Must possess excellent leadership, communication, presentation, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position 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.