Role overview

Qualifications

Physician (MD) with a medical thesis
Minimum of 4 years of active clinical practice experience
Specialization in Pulmonology, Immunology, Internal Medicine, Infectious Diseases, Family Medicine, Pediatrics, Rheumatology or Emergency Medicine
Experience in pharma industry or CRO in medical or project management

Responsibilities

Medically responsible at the trial level throughout the preparation, conduct, and reporting phases of the clinical trial
Provide medical expertise and oversight from the Trial Design Outline to the Clinical Trial Report
Ensure timely preparation of high medical quality clinical trial protocols
Contribute to trial risk-based quality management

Key facts

Remote from: United Kingdom, Germany
Full time
Mid-level (2-5 years)
English

Hard skills

Clinical Auditing Clinical Trial Management Systems Regulatory Compliance Clinical Practices Risk Management Pharmacovigilance Data Visualization Clinical Monitoring

Other skills

Empathy
Teamwork

About the company

Parexel

Pharmaceuticals

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company details

Company typeXLarge

IndustryPharmaceuticals

Company size10001

Links

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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