Medical Monitor/Study Physician/Medical Director - Home Based - FSP

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is currently seeking an experienced Study Physician to join us in the UK or Germany. You be assigned to one of our key sponsors in the EMEA region. Working as a Study Physician you will be medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, you will be responsible to provide medical expertise and medical oversight from the Trial Design Outline to the Clinical Trial Report. This is a core role within the trial team. Some specifics about this advertised role Dedicated to one client. Ensure timely preparation of high medical quality clinical trial protocols, minimising protocol amendments. Contribute to trial risk-based quality management, by defining medically relevant data and related risks are integrated into the quality and risk management plan. Co-author Clinical Quality Monitoring plans. Performing ongoing reviews of medical data. Here are a few requirements specific to this advertised role. Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of 4 years of active clinical practice experience; specialization in any of the following: Pulmonology, Immunology, Internal Medicine, Infectious Diseases, Family Medicine, Pediatrics, Rheumatology or Emergency Medicine is highly desirable. Experience in pharma industry or CRO in medical or project management or global pharmacovigilance functions/ any other relevant medical function ideally in Clinical Development is desirable. Understanding of relevant regulations and guidance including ICH-GCP. Ideally previous experience as a medical monitor Ideally experienced with data visualization systems and IT systems. Clinical development/trials experience which would be an additional asset