Global Study Associate Director - Single Sponsor Dedicated

About the role

The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, focused on delivering clinical studies. The GSAD leads a cross-functional study team, guides it toward successful delivery and acts as the main link between the study team and the Clinical Program Team (CPT) from study handover through close-out and archiving. The role is dedicated to a single sponsor.

Key responsibilities

• Lead and guide a cross-functional study team or oversee outsourced delivery so that milestones are met on time, within budget and to quality standards; may oversee several studies.
• Facilitate communication across functions, including external partners and service providers, and lead investigator and study meetings.
• Contribute to and own the development of study documents from the Clinical Study Protocol (CSP) to the Clinical Study Report (CSR).
• Monitor external service providers (CROs, central laboratories, IXRS, ePRO, etc.) against contract goals and timelines, document oversight and escalate issues; may take part in vendor selection.
• Develop study plans and quality and risk management plans, keeping risk responses and escalation paths clear.
• Keep study data in systems such as ACCORD/ABACUS and PharmaCM current and accurate, and track performance against KPIs, reporting risks and proposed mitigations to the CPT and sDSM/DSM.
• Report quality issues and CAPAs, and ensure the Trial Master File (TMF) is complete, with a plan, expected document list and ongoing quality checks.
• Ensure compliance with governance controls (Delegation of Authority, Sunshine Act, financial attestations, Clinical Trial Transparency) and keep studies inspection-ready under ICH-GCP; act as the primary Study Management contact for audits and inspections.
• Manage the study budget after the initial estimate from the CPT, giving budget progress reports and financial risk mitigations.
• Give regular performance feedback, mentor less experienced colleagues, and take on non-drug project work or act as a subject matter expert.

Required profile

• University degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research.
• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years' project management experience, or an equivalent combination of education, training and experience.
• Extensive knowledge of ICH-GCP and clinical research regulatory requirements, with proven clinical study management skills.
• Strong team leadership, stakeholder relationship building, conflict management, communication, strategic thinking, organization, problem solving and ability to manage competing priorities.