Medical Monitor
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Job Description
PSI is seeking a Medical Monitor (Oncology) to join our international Medical Monitoring team.
In this role, you will provide medical oversight and expertise across global clinical trials, working closely with study sponsors, investigators, sites, project teams, and other clinical research professionals. Your contribution will help protect participant safety, maintain scientific and medical quality, and support the successful delivery of oncology studies.
This is an opportunity to apply your clinical oncology experience to international research and contribute directly to the development of new treatments for patients who need them.
Full-time employment
Responsibilities:
Serve as primary medical point of contact for clinical trial sponsors, internal project teams, investigators and trial sites for medical matters related to the conduct of clinical trials per protocol and per GCP guidelinesProvide medical oversight throughout the conduct of clinical trials, in accordance with the protocol, applicable regulations, and ICH-GCP requirementsRespond to medical questions from investigators, sites, sponsors, project teams, and third-party vendorsProvide medical input into eligibility assessments, protocol deviations, participant safety issues, and other trial-specific medical mattersContribute medical expertise to clinical development plans, protocols, investigator brochures, informed consent documents, annual reports, clinical study reports, patient narratives, and scientific presentationsReview and assess clinical and safety data to support participant safety and identify medically relevant trends, risks, or quality concernsPrepares and delivers medical training and/therapeutic area training to investigators and study teamsSupport medical data review activities and contribute to the assessment of aggregated clinical trial dataParticipate in bid defense meetings and proposal activitiesProvide support with Pharmacovigilance activitiesIdentify medical trial risks, and collaborate with relevant functions to define appropriate mitigation and escalation measuresSupport or participate in advisory boards, safety monitoring boards, and other medical or scientific committees, as applicable.Help ensure that trial conduct and medical oversight activities comply with the approved protocol, applicable regulatory requirements, and quality standardsQualifications
You will be a strong fit for this role if you have
Medical Doctor degreeBoard certification in OncologyPrevious experience as a practicing OncologistPrevious experience in clinical research or the pharmaceutical or CRO industry is a plusFull professional proficiency in written and spoken EnglishStrong medical judgement, analytical thinking, and attention to detailClear communication and presentation skills, with the ability to explain complex medical information to different stakeholdersA collaborative and solution-oriented approach to working within international, cross-functional teams.Proficiency in Microsoft Office applications and confidence working with clinical trial systems and digital collaboration tools.