Associate Director, Study Management - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

About AstraZeneca
AstraZeneca is a global, science-led, patient-centric biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. Join the team dedicated to BioPharmaceutical Development.

About the role

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).

Provide oversight for Study Supply Management activities, ensuring delivery across a breadth of supply functions within the LCS matrix. Responsible for risk management, and as appropriate resolves or escalates identified risks and issues.
Independently plan, manage and deliver all aspects of Investigational Medicinal Product (IMP) supply from protocol concept to study completion for assigned clinical studies. Manages within agreed constraints of time, budget and quality.
Work collaboratively within Logistics and Clinical Supply (LCS), and with all other interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution.
Shape solutions and ensure that business requirements are effectively met. Advise and develop improvements appropriate to ongoing seamless and efficient Study Management practices within LCS.
Play an active role in the operational leadership of the LCS team.

Responsibilities:

Play an active role in technical management of LCS Study Managers, including technical direction/support and input to the definition of robust Study Manager assignments.
Where necessary ensure project continuity through key transition events and staff absences.
Influence, own and promote functional deployment of tools and procedures to create documentation required to support IMP supply activities.
Ensure that Study Manager input into studyrelated documents and activities is relevant, accurate and timely.
Provide oversight of the activities related to processing of product complaints, nonconformances, product recalls or enquiries pertaining to assigned clinical studies
Maintain and expand close crossfunctional relationships while proactively seeking information pertaining to clinical studies to best design, plan and implement Study Management activities for all relevant projects.
Ensure representation of all matrix functions (Study, Vendor, Distribution and Systems management) at the Supply Continuity Team (SCT).
As a member of the SCT contribute 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 interface with the SCT to ensure ongoing 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.
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 stakeholder communications.
Support analysis and advise on development of Study Management scope and activities to improve efficiency and enable robust interfaces and/or execution.
Actively engage in the creation and maintenance of LCS department SOPs and aligned guidance documents or other work instructions and training materials. Ensure procedures are maintained as accurate, enterprise aligned (where required) and reflective of current best practice.
Represent LCS in cross functional initiatives of moderate business impact, such as would benefit the design and establishment of organizational processes
Mentor, develop and supervise the daily activities of LCS staff acting either as Technical Manager or in rel