Global Study Lead - Clinical Operations

AstraZeneca; Durham (AR); On-site; USD 120,000 - 181,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentives

Paid time off

Benefits package

Job summary

AstraZeneca is seeking a Global Study Manager to support delivery of clinical studies across the lifecycle, from CSP through CSR and archiving. The GSM partners with internal and external stakeholders to ensure on-time, on-budget, compliant study execution according to the Delivery Model and ICH-GCP.

The role emphasizes cross-functional collaboration, vendor management, and proactive risk mitigation, with a focus on quality and inspection readiness within a global framework.

Qualifications

• Bachelor’s degree in medical, biological or related clinical research field.
• Minimum 3 years of relevant pharmaceutical/biotech/clinical research experience.
• Knowledge of clinical development and regulatory requirements (ICH-GCP).
• Excellent communication and stakeholder management skills.
• Experience managing external service providers/CROs.

Responsibilities

• Partner with internal teams and CROs to ensure study delivery within timelines and budget.
• Lead preparation of study documents and master agreements, specifications, and presentations.
• Coordinate interactions between internal functions, CROs and vendors for timely execution.
• Support planning of investigator and monitor meetings and TMF documentation.
• Assist with budget management, invoicing, and vendor tracking.

Skills

Clinical Study Management

GCP Compliance

Vendor Management

Budget Tracking

Cross-functional Collaboration

Stakeholder Management

Education

Bachelor's degree in medical, Biological, Life Sciences

Advanced degree preferred

Job description

AstraZeneca is seeking a Global Study Manager to support delivery of clinical studies across the lifecycle, from CSP through CSR and archiving. The GSM partners with internal and external stakeholders to ensure on-time, on-budget, compliant study execution according to the Delivery Model and ICH-GCP.

The role emphasizes cross-functional collaboration, vendor management, and proactive risk mitigation, with a focus on quality and inspection readiness within a global framework.