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.
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 and Board-certified specialist in Internal Medicine.
Prior and wide 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.
