Medical Monitor (Gastroenterology) at PSI CRO

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

12 Oct, 26

Salary

0.0

Posted On

14 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Planning, Regulatory Compliance, ICH GCP Guidelines, Data Analysis, Leadership, Communication, Problem Solving, MS Office

Industry

Pharmaceutical Manufacturing

Description

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, Office location: Tokyo or Osaka 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. 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.

Responsibilities

Provide medical expertise to clients and project teams to ensure the safety of study participants and the accuracy of clinical data. Collaborate on the preparation of clinical development plans, protocols, and regulatory documents while managing program risks.