Medical Director/Study Physician - CD Inflammation - Remote - Sponsor Dedicated

Parexel; United States; A distancia; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Parexel is seeking an experienced Study Physician to join us in the UK or Germany. You will be medically responsible at the trial level throughout preparation, conduct and reporting phases of clinical trials, providing medical expertise and oversight from design to the Clinical Trial Report.

Requirements include MD with at least 4 years of active clinical practice; subspecialty in pulmonology, immunology, internal medicine, infectious diseases, family medicine, pediatrics, rheumatology, or

Formación

• Physician (MD) with minimum of 4 years of active clinical practice.
• Specialization in pulmonology, immunology, internal medicine, infectious diseases, family medicine, pediatrics, rheumatology or emergency medicine is highly desirable.
• Experience in pharma/CRO medical or project management/ pharmacovigilance in Clinical Development is desirable.

Responsabilidades

• Provide medical oversight from trial design to Clinical Trial Report.
• Ensure high quality clinical trial protocols with minimal amendments.
• Co-author Clinical Quality Monitoring plans and review medical data throughout the trial.
• Contribute to trial risk management by defining medically relevant data and risks.

Conocimientos

MD

Clinical practice 4 years

ICH-GCP knowledge

Medical monitor exp

Educación

MD

Descripción del empleo

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 Pulmonology, Immunology, Internal Medicine, Infectious Diseases, Family Medicine, Pediatrics, Rheumatology, and 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