Global Study Associate Director

The Global Study Associate Director (GSAD) is a pivotal role within Study Management, BioPharmaceuticals Clinical Operations, responsible for the delivery of clinical studies. As the leader of a cross-functional study team, the GSAD provides direction and mentorship to ensure successful study delivery. Acting as the main liaison between the study team and the Clinical Program Team (CPT), the GSAD leads all aspects of the study from handover through to close-out and archiving. The GSAD ensures that studies are delivered on time, within budget, and to the highest quality standards by encouraging effective partnerships and teamwork within the study team and with external partners.

Accountabilities

• Lead, guide, and delegate tasks to a cross-functional study team or supervise outsourced delivery activities to ensure clinical study progress according to timelines, budget, and quality standards.
• Facilitate communication across all functions, including external partners and service providers, and lead investigator meetings and other study-related meetings.
• Develop and maintain essential study-level documents in accordance with relevant AZ SOPs.
• Ensure external service providers meet contracted goals and timelines/budget, document adequate oversight, and raise any issues appropriately.
• Develop and maintain relevant study plans, including quality and risk management planning, ensuring clear risk response strategies and issue partner concern pathways.
• Oversee study performance against agreed plans, achievements, and critical metrics using company tracking systems and communicate risks to timelines/quality to CPT and sDSM/DSM with proposed mitigations.
• Identify and report quality issues within the study, collaborate with functions to overcome barriers, and communicate findings and corrective action plans to stakeholders.
• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs.
• Ensure studies are always inspection-ready according to ICH-GCP and AZ SOPs.
• Provide regular feedback on individual performance to study team members and their line managers.
• Work on non-drug project work such as process improvements or leading improvement projects.
• Act as Subject Matter Authority for specific processes or systems within Study Management.

Essential Skills/Experience

• B.S. degree in biological sciences or subject area associated with clinical research.
• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training, and experience
• Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development.
• Demonstrated solid project management skills and knowledge of relevant tools.
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and partners, along with strong conflict leadership skills.
• Excellent communication and interpersonal skills
• Strong strategic and critical thinking abilities along with organizational and problem-solving skills
• Ability to manage competing priorities.

Desirable Skills/Experience

• Masters level degree or greater.
• Project management certification.
• Proven project management experience on a global level.
• Experience in all phases of a clinical study lifecycle.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are committed to exploring what science can do. Our dynamic environment encourages creativity, resilience, and bold decision-making. We are dedicated to treating, preventing, modifying, and curing some of the world's most complex diseases. By fusing data and technology with scientific innovation, we aim to achieve groundbreaking breakthroughs that positively impact billions of patients worldwide. Our inclusive environment fosters collaboration across academia, biotech’s, and industry to create swift impacts on disease. With numerous opportunities for learning and career development, AstraZeneca is where you can build a meaningful career while pushing the boundaries of science.

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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 authorization and employment eligibility verification requirements.