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CK Group is recruiting for a Global Studies Asset Manager to join a company in the pharmaceutical industry on a contract basis for 6 months. Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing, and providing over 160 different medicines, vaccines, and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Job Responsibility:
Coordinate and deliver the study management aspects of a group of studies within an asset’s portfolio
Provide input into the development of essential study-level documents (e.g., study protocol, TMP, Pharmacy manual)
Develops a study's recruitment expectations and maintains a forecast using the appropriate systems
Develop and/or maintain or provide input in collaboration with CRO partners, study management essential documents (e.g Pharmacy manual, relevant study plans)
Maintain inspection readiness of the relevant components in the scope of responsibility
Lead 3rd party vendor selection, Vendor identification set up, and oversight and close out to ensure delivery to contract (in line with relevant iCOP strategies and study level needs)
Produce, arrange translation & distribute patient and site-facing support materials
Manage the supply and shipment of IMP
Requirements:
Have a minimum of 3 years of relevant clinical operations experience (clinical trial management)
Hold a university degree or equivalent years of experience, with a preferred focus in life sciences
Possess a strong working knowledge of the drug development process and respective regulations, including ICH and GCP guidelines
Demonstrable experience of delivery in the pharmaceutical industry within clinical operations
Excellent coordination and delivery expertise in study management.