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Clinical Manager - United Kingdom - Parexel
Description
Parexel is in the business of improving the world's health.We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.
From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
Patients First, Quality, Respect, Empowerment & Accountability.Parexel is looking for a Medical Director/Senior Medical Director with a strong background in Oncology.
The role can be based remo t ely in the UK or select EMEA locations. Must have ex perience in clinical medicine with a specialty in Oncology which has been kept up to date.
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development.
They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects.
The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
Project Execution:
Medical Monitoring Delivery & PV Support
Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., Participate actively in study planning with feasibility leaders, solution consultants
Participate in team project and investigator meetings
Provide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management)
Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study
Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc.
Deliver medical monitoring activities according to MMP during the study conductDeliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLP
Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events
Client Relationship Building & Engagement
Provide medical expertise to client across multiple channels and interactions
Medical review of various documents, which might be audited by clients and regulatory agencies
Provide medical expertise and training to other Parexel colleagues
Very strong experience in clinical medicine with a specialty in Oncology which has been kept up to date.
A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution preferred.
Experience in Pharmaceutical Medicine, preferred
Excellent English language skills
Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
LI-REMOTE
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