Study Manager

Barcelona onsite role - 3 days at the office / 2 days at home

Introduction to role

As a Study Manager, you will provide oversight for Study Supply Management activities, coordinating across supply functions within the LCS matrix. You will independently plan, manage, and deliver all aspects of Investigational Medicinal Product (IMP) supply for assigned clinical studies. Working collaboratively within Logistics and Clinical Supply (LCS) and with all other interfaces and stakeholders internally and externally, you will ensure highly effective clinical supply planning and execution. Your experience will be crucial in developing supply strategies and influencing to ensure that any issues are appropriately managed, seamlessly achieving Biopharmaceutical Development (BPD) project goals and milestones. You will also develop and follow functional policies and best practices, contributing to the operational effectiveness of LCS.

Accountabilities

- Work within a matrix team to plan, manage, and deliver IMP supply for assigned clinical studies.
- Use defined tools and procedures to create documentation required to support IMP supply.
- Provide input into relevant study-related documents.
- Maintain IMP study documentation in defined document repositories for GXP purposes.
- Ensure necessary IMP-related documentation is available to service the Product Specification File.
- Maintain oversight of activities related to processing product complaints, non-conformances, product recalls, or inquiries pertaining to IMP received from clinical sites, depots, or couriers.
- Collaborate effectively within LCS to coordinate Vendor, Distribution, and Systems management activities for assigned projects.
- Create, develop, and maintain LCS agreed clinical supply plan for IMP.
- Lead regular LCS Matrix Team meetings and coordinate on scope of work, detailed plans, and timelines with Systems, Distribution, and Vendor Management representatives.
- Ensure responsiveness to changes in supply remit and timely resolution of issues and challenges as they arise.
- Manage dynamic project demand forecasts and production planning for assigned clinical studies using Smart Supplies Forecasting and Planning.
- Liaise closely with relevant teams and suppliers regarding the delivery of materials.
- Communicate information to the Vendor Manager responsible for creating and managing the study budget.
- Represent LCS as an engaged participant at the Clinical Trial Team (CTT) when appropriate.
- Develop close cross-functional relationships to support activities associated with IMP release.
- Liaise closely with Quality Assurance (QA) to ensure all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines.
- Resolve routine issues in partnership with key interfacing roles to ensure supply continuity and escalate issues when necessary.
- Communicate and provide input into risk management plans.
- Attend and actively participate in departmental meetings.
- Develop and streamline processes within own team or area.
- Manage the reconciliation and destruction of DP/IMP supplies for study close-out.
- Mentor, develop, and supervise the activities of other members of co-workers assigned to flexible roles within the Distribution team.
- Own delivery of clinical study supply for assigned clinical studies.
- Undertake operational and tactical planning to deliver against business requirements professionally and efficiently.
- Undertake process planning, communicate objectives, and monitor performance to ensure delivery against agreed targets.
- Monitor and maintain compliance with current cGMP, GDP, GCP, & ICH guidelines.
- Develop and follow policies and procedures in executing activities.
- Communicate and align to ensure appropriate quality service delivery.
- Optimize performance outcomes of cross-functional teams.
- Act as a point of contact to third-party suppliers providing services to AZ.
- Promote continuous improvement by identifying and delivering performance improvements.

Essential Skills/Experience

- Bachelor's degree in basic/applied science or engineering. Equivalent level of training in service may be considered
- Stakeholder management in a customer-facing role, partnering to achieve objectives
- Direct experience in a Development or Technical Operations environment in the pharmaceutical, scientific or healthcare industry
- Working knowledge of challenges in delivery of international clinical studies, with focus on IMP supply & management
- A good understanding of cGMP, GCP, and ICH guidelines as related to IMP management, and a sound understanding of the drug development process
- Ability to work in a dynamic environment, and collaborate effectively within cross-functional teams to deliver complex projects
- Experience managing delivery of complex projects through internal or external suppliers/cross-functional teams
- Highly organized team worker with excellent attention to detail and strong communication skills
- Strong analytical skills, excellent attention to detail, and aptitude for technical troubleshooting
- IT proficiency appropriate to a systems-driven manufacturing role

Desirable Skills/Experience

- Change responsive
- Influencing and negotiation skills
- Process development/process management experience
- Management skills appropriate to an effective mentor
- Experience in IMP management
- Oversight of vendors performing GMP operations

At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. With science at its heart, this is where breakthroughs born in the lab become transformative medicine for the world’s most complex diseases. We strive to understand the needs of diverse populations and act accordingly. Our ground-breaking pipeline offers exciting opportunities as we lead the way for healthcare and society.

Join us on our journey to pioneer the future of healthcare. Apply today!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.