Job Title: Global Study Associate Director Location: Durham, NC Introduction to role: Are you ready to lead global clinical studies that turn cutting-edge science into evidence that changes patients’ lives? In this role,…
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$138k–$207k/yr
Full-time
bachelor degree, postgraduate degree
Qualified retirement programs, Paid time off, Health coverage, Dental coverage, Vision coverage, Short-term incentive bonuses
Posted 15d ago
Apply by Sep 15
~40 hrs/week
Responsibilities
The Global Study Associate Director leads cross-functional teams to deliver complex clinical studies on time, within budget, and in compliance with quality standards. They are responsible for vendor oversight, risk management, and maintaining inspection readiness throughout the study lifecycle.
Requirements
Candidates must hold a bachelor's degree in a relevant scientific field and possess at least 5 years of clinical research experience, including 2 years of project management. Strong knowledge of ICH-GCP and regulatory requirements is essential for this role.
Full job description
Job Title: Global Study Associate Director
Location: Durham, NC
Introduction to role:
Are you ready to lead global clinical studies that turn cutting-edge science into evidence that changes patients’ lives? In this role, you will own the end-to-end delivery of complex studies, guiding cross-functional teams and external partners from handover to close-out and archiving, so our medicines can reach those who need them faster.
You will operate at the center of study execution—aligning strategy with action, translating risk into robust plans, and making data-driven decisions that safeguard quality, timelines, and budget. Working with knowns and unknowns, you will champion clarity, pace, and accountability while shaping how we use digital, data, and technology to advance clinical development.
What could you accomplish by uniting diverse experts around a clear plan—and keeping a global study inspection-ready, on budget, and ahead of schedule?
Accountabilities:
Study Leadership and Delivery: Lead and empower a cross-functional study team and/or oversee outsourced partners to deliver against agreed timelines, budget, and quality standards; hold accountability for one or several studies and drive milestone achievement.
Cross-Functional and External Communication: Orchestrate clear, timely communication across functions and vendors; plan and lead investigator meetings and key study forums to maintain alignment and momentum.
Study Documentation Ownership: Provide input to and hold accountability for essential study documents from Clinical Study Protocol through Clinical Study Report in line with SOPs and regulatory requirements.
Vendor Strategy and Oversight: Ensure CROs and other vendors (e.g., central labs, IXRS, ePRO) deliver to contract, timeline, and budget; document oversight, escalate issues, and support vendor selection when needed.
Quality and Risk Management: Build and maintain risk-based quality plans, proactive risk and contingency strategies, and clear escalation pathways; champion a culture of issue prevention and rapid resolution.
Data and Systems Integrity: Ensure accuracy and currency of study-level systems (e.g., ACCORD/ABACUS, PharmaCM); use operational data to drive decisions and transparency.
Performance and KPI Management: Monitor operational and quality KPIs, track progress against plans, and communicate risks, mitigations, and impacts to study leadership and the Clinical Program Team.
Issue Management and CAPA: Identify, report, and resolve quality issues; coordinate corrective and preventive actions with stakeholders and communicate outcomes to CPT, QA, and functional leaders.
Trial Master File Excellence: Oversee TMF strategy, plan, and Expected Document List; ensure ongoing QC and continuous inspection readiness.
Compliance and Governance: Secure timely compliance with governance controls (e.g., Delegation of Authority, Sunshine Act, clinical trial transparency) and uphold ICH-GCP, SOPs, policies, and best practices.
Budget Ownership: Re-forecast and manage the study budget throughout the lifecycle; provide clear budget status, risks, and mitigations to the CPT and drive disciplined change control.
Inspection Readiness: Serve as the primary Study Management point-of-contact during audits or inspections; maintain a constant state of readiness with robust documentation and processes.
People Development and Mentoring: Provide ongoing feedback to team members and line managers; mentor less experienced colleagues to build capability across the organization.
Continuous Improvement and SME Contributions: Lead or contribute to non-drug project work, process enhancements, and act as a subject matter expert for Study Management systems or processes.
Essential Skills/Experience:
Bachelors degree (or equivalent), preferably in medical or biological sciences or discipline 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, demonstrated abilities/skills in team leadership
Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills
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.
Why AstraZeneca:
Here you will join a research-driven organization that pairs scientific depth with digital and data capabilities to tackle some of the most complex diseases of our time. We bring together diverse experts—clinicians, data scientists, operations leaders, and partners from academia and industry—to accelerate evidence generation and sharpen trial predictability. You will be trusted to think differently, to test bold ideas, and to learn quickly, supported by leaders who prize clarity, curiosity, and kindness alongside ambition. Your decisions will shape study outcomes that can influence care pathways globally and bring transformative medicines to patients sooner.
Step into a role where your leadership will speed pivotal studies and amplify patient impact—let’s shape the next wave of clinical breakthroughs together!
The annual base pay (or hourly rate of compensation) for this position ranges from $137,937.60 - $206,906.40 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
28-Aug-2026
Closing Date
14-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Related keywords
Clinical ResearchPharmaceutical IndustryICH-GCPProject ManagementClinical Study ProtocolClinical Study ReportCROVendor ManagementRisk-based Quality PlansTrial Master FileTMFInspection ReadinessKPI ManagementCAPABudget ForecastingRegulatory Requirements
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com.
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Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
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How much do Management & Leadership jobs in Durham, NC pay?
Based on 696 listings with disclosed salaries, most management & leadership jobs in Durham, NC pay between $50k–$225k per year. Individual offers vary with seniority, company size, and specialization.
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