Location: Barcelona, Spain (On-site): We require 3 days working from the office and 2 days working from home. Join our Biopharmaceuticals R&D team as an Associate Director, Study Management. In this role, you will provide oversight for Study Supply Management activities, ensuring delivery across a breadth of supply functions within the LCS (Logistics and Clinical Supply) matrix. You will independently plan, handle and deliver all aspects of Investigational Medicinal Product (IMP) supply from protocol concept to study completion for assigned clinical studies. This is an opportunity to work with curious minds in an inclusive culture where all doors are open, and every voice is heard.Typical Accountabilities:Provide general oversight for Study Management activities within LCS ensuring highly effective planning and management of IMP supply for clinical studies.Play an active role in technical management of LCS Study Managers, including technical direction/support and input to definition of robust Study Manager assignments.Where necessary ensure project continuity through key transition events and staff absences.As required provide direct oversight and supervision to specified studies led by other members of the Study Management group.Independently plan, manage and deliver IMP supply for assigned clinical studies.An Associate Director, Study Management will typically have direct responsibility for management of multiple studies involving diverse development compounds and/or external collaboration based studies as required. Studies may be domestic and/or international in scope and will include complex operations associated with later phase clinical trials, or in provision of Auxiliary Medicinal Products (AMP).Influence, own and promote functional deployment of tools and procedures to catalogue required to support IMP supply activities.Ensure that Study Manager input into study related documents and activities is relevant, accurate and timely.Provide oversight of the activities related to processing of product complaints, non-conformances, product recalls or enquiries pertaining to assigned clinical studies.Throughout each project lifecycle, promote and ensure maintenance of current, accurate and complete IMP related study documentation (hard copy and electronic as appropriate).Enable that all vital files are uploaded in a timely manner to the Trial Master File (TMF), appended to the Product Specification File (PSF), or made available within other relevant GXP system as required.Maintain and expand close cross-functional relationships while proactively seeking information pertaining to clinical studies to best design, plan and implement Study Management activities for all relevant projects.Collaborate within LCS to ensure highly effective matrix working including closely coordinated delivery of Study, Vendor, Distribution and Systems management activities for each relevant study.#J-18808-Ljbffr
