Global Study Manager

Biopharma Careers; North Carolina; On-site; USD 120,000 - 181,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Long-term incentives

Paid time off

Health benefits

Job summary

AstraZeneca is seeking a Global Study Manager to lead delivery of clinical studies in collaboration with internal teams, CROs, and vendors, ensuring timelines, budgets, and quality from CSP to CSR and archiving.

Required: degree in life sciences, 3+ years in pharma/clinical research, strong ICH-GCP knowledge, and excellent communication. Advanced degree preferred.

Qualifications

• Bachelor's degree in medical, biological, life sciences or related clinical research discipline.
• Minimum of 3 years of relevant experience in pharma, CRO, biotech or academic clinical research.
• Knowledge of clinical development and drug development processes across phases and therapeutic areas.
• Strong understanding of ICH-GCP and global clinical trial regulations.
• Excellent communication, collaboration and stakeholder management.
• Experience managing external service providers/CROs.
• Demonstrated project management skills.
• Ability to work independently and in cross-functional teams.
• Demonstrated leadership and problem-solving capabilities.
• Strong computer proficiency and experience with clinical systems.

Responsibilities

• Partner with internal clinical teams, SMEs, CROs and external providers to ensure successful study delivery.
• Lead preparation of study documents including ICFs, master agreements, study procedures and specifications.
• Coordinate interactions between internal functions, CROs and vendors to support timely, on-budget, quality study execution.
• Support planning and execution of internal and external meetings (investigator and monitor meetings).
• Ensure supply of investigational product and study materials with Clinical Supply Chain and partners.
• Identify risks and contribute to mitigation plans.
• Maintain TMF documentation accurately and completely.
• Support budget management including invoice reconciliation and vendor tracking.
• Adhere to global clinical processes and regulations to ensure inspection readiness.
• Provide project management support to GSD/GSAD as delegated.
• Oversee CRO Project Managers for outsourced studies to ensure timelines, budgets and quality.
• Participate in process improvements and lead non-drug project work.

Skills

Clinical Trial Management

Vendor Management

Project Management

Communication

Cross-functional Collaboration

Education

Bachelor's degree in life sciences

Tools

Clinical systems

Budget tools

Job description

The Global Study Manager (GSM) is a member of the extended global study team supporting the delivery of clinical studies within BioPharmaceuticals Clinical Operations. The GSM is responsible for supporting study management activities to ensure delivery to agreed timelines, budget, and quality standards, from Clinical Study Protocol (CSP) development through study start-up, maintenance, close-out, Clinical Study Report (CSR) development, and study archiving.

Key Responsibilities

• Partner with internal clinical teams, subject matter experts, CROs, and external service providers to ensure successful study delivery.
• Lead and contribute to preparation of study documents, including informed consent forms, master clinical study agreements, study-specific procedures, specifications, presentations, and other required documents.
• Coordinate and facilitate interactions between internal functions, CROs, and external vendors to support efficient study execution within timeline, budget, and quality expectations.
• Support the planning and execution of internal and external meetings, including investigator and monitor meetings.
• Ensure investigational product and study material supply through collaboration with Clinical Supply Chain and external partners.
• Identify study risks and issues proactively and contribute to mitigation and action plans.
• Ensure study-related documentation within assigned scope is complete, accurate, and maintained in the Trial Master File (TMF).
• Support budget management activities, including invoice reconciliation and vendor financial tracking.
• Adhere to global clinical processes, Quality & Compliance requirements, and international regulations to ensure inspection readiness at all times.
• Provide project management support to the GSD and/or GSAD as delegated.
• Support management and oversight of CRO Project Managers for outsourced studies, ensuring delivery against agreed timelines, budgets, and quality standards while maintaining appropriate documented oversight.
• Participate in process improvement initiatives and lead non-drug project work as assigned.

Education and Qualifications

Required

• Bachelor's degree in medical, Biological, Life Sciences, or a related clinical research discipline.
• Minimum of 3 years of relevant experience within the pharmaceutical industry, contract research organization, biotechnology company, or academic clinical research environment.
• Knowledge of clinical development and drug development processes across multiple phases and therapeutic areas.
• Strong understanding of ICH-GCP and global clinical trial regulations.
• Excellent communication, collaboration, and stakeholder management skills.
• Experience managing external service providers and/or CROs.
• Demonstrated project management skills.
• Ability to work effectively both independently and within cross-functional teams.
• Demonstrated leadership and problem-solving capabilities.
• Strong computer proficiency and experience using clinical systems and business applications.
• Excellent written and verbal communication skills in English.

Preferred

• Advanced degree (Master's, PharmD, PhD, or equivalent).
• Experience across the full clinical study lifecycle from start-up through close-out.
• Knowledge of additional GxP areas, including GMP and GLP.
• Experience supporting global clinical studies and outsourced delivery models.

People Management

No direct reports.

May provide matrix leadership and study team coordination across internal and external stakeholders.

Functional Skills

• Clinical Trial Management
• Clinical Operations
• GCP / ICH Compliance
• Vendor Management
• CRO Oversight
• Study Documentation Management
• Trial Master File (TMF) Management
• Risk Management
• Budget Tracking and Reconciliation
• Cross-functional Collaboration
• Project Management
• Stakeholder Management

Why AstraZeneca

Here, your start-up leadership shapes the path from promising data to approved medicines. You will work on assets at different stages, influence strategy early, and collaborate with experts who bring science, operations, and technology together in the same room to unlock faster decisions. We balance bold ambition with genuine support, valuing kindness alongside drive, and encourage you to question, experiment, and harness new tools that shorten development cycles and amplify patient impact. Step into a role where your expertise activates studies faster and strengthens approvals, bring your start-up leadership to AstraZeneca and create momentum that matters now!

Benefits

• Competitive base salary, annual bonus, and long-term incentives
• Generous paid time off program
• Comprehensive benefits package
• The annual base pay (or hourly rate of compensation) for this position ranges from $120,355.20 - $180,522.80 USD Annual , either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]
• Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.
• Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
• In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Diversity and Inclusion at AstraZeneca

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive team that represents a diverse group of backgrounds and perspectives, knowing that inclusion drives better outcomes.We welcome all qualified candidates and align with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations during the application or interview process, as well as for essential job functions.

Date Posted 10-Sep-2026

Closing Date 24-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.