Global Study Manager for Clinical Trials Delivery

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

Benefits offered by this job

Competitive base salary and annual bon

Long-term incentives

Generous paid time off

Comprehensive benefits package

Job summary

AstraZeneca is seeking a Global Study Manager to support delivery of clinical studies within BioPharmaceuticals Clinical Operations. You will partner with cross-functional teams and external partners to ensure timely, within-budget study execution, from CSP development through CSR and archiving.

The role emphasizes ICH-GCP compliance, TMF maintenance, risk management, and budget oversight, with opportunities to lead process improvements and contribute to pivotal late-stage studies.

Qualifications

• Bachelor’s degree in medical, biological, life sciences, or related field.
• Minimum 3 years in pharma/ CRO/ biotech or academic clinical research.
• Knowledge of clinical development and regulatory processes.
• Strong ICH-GCP understanding and global trial regulations.
• Excellent communication and stakeholder management.
• Experience managing external service providers and/or CROs.
• Demonstrated project management and leadership capabilities.
• Ability to work independently and in cross-functional teams.
• Strong English written and verbal communication.

Responsibilities

• Partner with internal teams, CROs, and vendors to ensure study delivery.
• Lead preparation of study documents and agreements.
• Coordinate interactions to support timely, within budget, quality study execution.
• Support internal and external meetings including investigator meetings.
• Ensure supply of investigational product with Clinical Supply Chain.
• Identify risks and contribute to mitigation plans.
• Maintain TMF documentation and reconcile budgets.
• Provide project management support to GSD/GSAD.
• Oversee CRO project managers and ensure oversight.
• Participate in process improvements and non-drug project work.

Skills

Clinical Study Management

GxP/ICH Compliance

Stakeholder Management

Vendor Management

Budget Tracking

Risk Management

Project Management

Cross-Functional Collaboration

Leadership

Communication

Education

Bachelor’s degree in Life Sciences

Advanced degree (MS/PhD/PharmD)

Job description

AstraZeneca is seeking a Global Study Manager to support delivery of clinical studies within BioPharmaceuticals Clinical Operations. You will partner with cross-functional teams and external partners to ensure timely, within-budget study execution, from CSP development through CSR and archiving.

The role emphasizes ICH-GCP compliance, TMF maintenance, risk management, and budget oversight, with opportunities to lead process improvements and contribute to pivotal late-stage studies.