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.
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