Associate Director, Study Management
hace 5 meses
**Location: Barcelona**:
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 such as 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.
- Ensure representation of all matrix functions (Study, Vendor, Distribution and Systems management) at the Supply Continuity Team (SCT).
- As a member of the SCT supply to and influence the development /supply strategy, ensuring that the demand, risks and opportunities for supply optimization are discussed
- Enable creation, maintenance, and clear communication of supply strategy and aligned dynamic long range project demand forecast for assigned clinical studies.
- Liaise closely to ensure clear transfer of information to the Vendor group responsible for management of the study budget
- Represent LCS as an engaged and active participant at the Clinical Trial Team (CTT). Ensure clear information exchange in relation to current supply activities and influence for effective and timely consideration of any change scenarios that may impact supply plans. Provide dynamic talk to the SCT to ensure on-going responsiveness to any factors that may impact supply strategy, aligning planning and implementation of any agreed changes
- Liaise closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines
- Initiate non-conformances when identified and complete investigations to support on time closure of Trackwise records
- Partner with stakeholder departments (e.g. Quality Assurance, Analytical, clinical and Regulatory) to develop, communicate and deliver a risk mitigated supply strategy. Ensure that any issues relating to IMP release and supply to the clinic are highlighted and that solutions are provided for the project and for other similar projects in Development.
- Influence and enable development of optimal working practices, SOPs, systems and tools, to ensure robust Study Management execution and partner communications.
- Support analysis and advise on development of Study Management scope and activities to improve efficiency and enable robust interfaces and/or execution
- Lead departmental process improvement initiatives as required
- Actively engage in the creation and maintenance of LCS department S
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