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    Clinical Manager - United Kingdom - Parexel International

    Parexel International
    Parexel International United Kingdom

    3 weeks ago

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    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.

    We are going to be hiring a Medical Director/Senior Medical Director in the next couple of months so are beginning to talent pool in preparation.

    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 Infectious Diseases 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 conduct
    Deliver 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 Infectious Diseases 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 #J-18808-Ljbffr
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