Global Study Associate Director

AstraZeneca•Durham, NC

2d•$137,938 - $206,906•Hybrid

About The Position

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?

Requirements

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 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
Excellent communication and interpersonal skills
Strong strategic and critical thinking abilities
Strong organizational and problem-solving skills
Ability to manage competing priorities

Nice To Haves

Advanced degree, Masters level education (or higher)
Project management certification
Proven project management experience on a global level
Experience in all phases of a clinical study lifecycle

Responsibilities

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.
Orchestrate clear, timely communication across functions and vendors; plan and lead investigator meetings and key study forums to maintain alignment and momentum.
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.
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.
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.
Ensure accuracy and currency of study-level systems (e.g., ACCORD/ABACUS, PharmaCM); use operational data to drive decisions and transparency.
Monitor operational and quality KPIs, track progress against plans, and communicate risks, mitigations, and impacts to study leadership and the Clinical Program Team.
Identify, report, and resolve quality issues; coordinate corrective and preventive actions with stakeholders and communicate outcomes to CPT, QA, and functional leaders.
Oversee TMF strategy, plan, and Expected Document List; ensure ongoing QC and continuous inspection readiness.
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.
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.
Serve as the primary Study Management point-of-contact during audits or inspections; maintain a constant state of readiness with robust documentation and processes.
Provide ongoing feedback to team members and line managers; mentor less experienced colleagues to build capability across the organization.
Lead or contribute to non-drug project work, process enhancements, and act as a subject matter expert for Study Management systems or processes.