Global Study Lead - Clinical Trials & Strategy

AstraZeneca GmbH; Durham (NC); Hybrid; USD 138,000 - 207,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision coverage

Retirement programs

Paid time off

Job summary

AstraZeneca in Durham, NC seeks a Global Study Associate Director to lead end-to-end delivery of complex clinical studies. You will guide cross-functional teams and external partners, ensuring timelines, budget, and quality while advancing data-driven decisions and digitization efforts.

Essential qualifications include a Bachelor’s degree, 5 years in pharma with PM experience, and strong ICH-GCP knowledge. The role involves hybrid in-office collaboration and global study oversight.

Qualifications

• Bachelor's degree in medical/biological sciences preferred.
• 5 years in pharma/clinical development with 2 years PM experience.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Proven PM skills and familiarity with PM tools.
• Leadership, collaboration, and stakeholder management abilities.
• Ability to manage competing priorities and timelines.

Responsibilities

• Lead cross-functional study teams and outsourced partners to meet timelines, budget, and quality.
• Coordinate communications across functions and vendors; plan investigator meetings.
• Own essential study documents from protocol to final report per SOPs.
• Oversee CROs/vendors to ensure delivery against contract and budget.
• Develop risk-based quality plans and contingency strategies.
• Ensure study systems data accuracy and transparency for decisions.
• Monitor KPIs, report risks, mitigations, and impacts to leadership.
• Identify and resolve quality issues; coordinate CAPAs with stakeholders.
• Oversee TMF strategy, document lists, and inspection readiness.
• Maintain governance compliance and regulatory standards.
• Own study budget forecasting and change control.
• Serve as PM contact during audits/inspections; ensure readiness.
• Mentor team members and contribute to continuous improvement.

Skills

Project management

Team leadership

Stakeholder mgmt

Communication skills

Strategic thinking

Organizational skills

Prioritization

Education

Bachelor's degree

Advanced degree

Masters level education

Tools

PM Certification

Job description

AstraZeneca in Durham, NC seeks a Global Study Associate Director to lead end-to-end delivery of complex clinical studies. You will guide cross-functional teams and external partners, ensuring timelines, budget, and quality while advancing data-driven decisions and digitization efforts.

Essential qualifications include a Bachelor’s degree, 5 years in pharma with PM experience, and strong ICH-GCP knowledge. The role involves hybrid in-office collaboration and global study oversight.