Global Study Manager

🎯 Role Definition

The Global Study Manager (GSM) is the central pillar of our clinical trial execution, acting as the project leader for assigned global studies. You will be accountable for delivering the study on time, within budget, and to the highest standards of quality and compliance (GCP/ICH). This role involves steering a matrixed, cross-functional team, managing complex vendor relationships, and proactively mitigating risks to ensure the integrity of the trial and the safety of our patients. You are the operational driver, translating scientific objectives into a flawless, executable clinical study plan.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Trial Manager / Clinical Project Manager
Senior Clinical Research Associate (Sr. CRA) with lead experience
Clinical Operations Lead

Advancement To:

Senior Global Study Manager / Principal Study Manager
Associate Director, Clinical Operations
Clinical Program Manager

Lateral Moves:

Alliance / Vendor Management
Clinical Science Liaison
Process Improvement / Operational Excellence Roles

Core Responsibilities

Primary Functions

Lead the global, cross-functional Study Management Team (SMT) to ensure alignment and successful execution of all operational aspects of the clinical trial.
Develop, manage, and meticulously track the overall study budget, including forecasting, accruals, and variance analysis to ensure strict financial control and reporting.
Create and maintain realistic, integrated study timelines, proactively identifying and communicating any risks or deviations to the plan and implementing mitigation strategies.
Oversee the selection, qualification, and performance management of external vendors, including CROs, central laboratories, and other third-party suppliers, ensuring adherence to contractual obligations and quality standards.
Ensure the clinical study is conducted in full compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable national and international regulatory requirements.
Drive the development and implementation of global patient recruitment and retention strategies in collaboration with the study team to meet or exceed enrollment targets.
Lead the development and finalization of key study-related documents, including but not limited to the clinical protocol, informed consent forms (ICFs), and various study management plans (e.g., monitoring, communication, risk management plans).
Act as the primary point of contact for all operational aspects of the study, facilitating clear and consistent communication between the study team, vendors, and senior management.
Proactively identify, assess, and manage study-level risks and issues, developing robust contingency plans and escalating significant issues to governance bodies as appropriate.
Chair and manage study team meetings, ensuring agendas are clear, minutes and decisions are documented, and action items are tracked to completion.
Prepare and present comprehensive study status updates, milestone achievements, and risk assessments to senior leadership and governance committees.
Guarantee the Trial Master File (TMF) is maintained in a state of constant inspection-readiness through oversight of document collection, review, and archival.
Oversee clinical trial site management activities, including site selection, start-up, monitoring, and close-out, to ensure data quality and site performance.
Manage the clinical trial supply chain (investigational product and ancillary supplies), ensuring accurate forecasting and timely distribution to global sites.
Provide operational input and review of clinical sections for regulatory submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and responses to health authority questions.
Lead the cross-functional effort to ensure timely data cleaning, database lock, and the completion of the Clinical Study Report (CSR).
Develop and execute a comprehensive quality oversight plan for the study, including co-monitoring visits and vendor audits, to ensure data integrity and patient safety.
Serve as a mentor and subject matter expert for junior members of the clinical operations team, providing guidance and fostering their professional development.
Facilitate investigator meetings, advisory boards, and other study-related events, ensuring they are executed efficiently and effectively.
Manage the entire lifecycle of protocol amendments, from conception through to implementation, ensuring minimal disruption to the study and full regulatory compliance.

Secondary Functions

Contribute to departmental process improvement initiatives and the development of Standard Operating Procedures (SOPs).
Participate in the evaluation and implementation of new technologies and systems to enhance clinical trial efficiency.
Support the clinical development team with operational feasibility assessments for new study concepts.
Collaborate with business units to translate data needs into engineering requirements.

Required Skills & Competencies

Hard Skills (Technical)

Clinical Project Management: Expert-level ability to manage all phases of a clinical trial lifecycle, including scope, timeline, budget, risk, and resources. PMP certification is a plus.
ICH/GCP & Regulatory Knowledge: Deep, applied understanding of ICH/GCP guidelines and global regulatory landscapes (e.g., FDA, EMA).
Vendor & CRO Management: Proven experience in selecting, contracting, and providing rigorous oversight of CROs and other clinical trial vendors.
Financial Acumen: Strong skills in budget development, forecasting, and financial management for complex, multi-year projects.
Risk Management: Formal knowledge and practical application of risk identification, assessment, and mitigation strategies in a clinical setting.
Clinical Systems Proficiency: Hands-on experience with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and eTMF systems.

Soft Skills

Leadership & Influence: Ability to lead and motivate a diverse, matrixed team without direct line authority, fostering a collaborative and high-performance culture.
Strategic & Critical Thinking: Capacity to see the bigger picture, anticipate future challenges, and make sound, data-driven decisions under pressure.
Communication & Interpersonal Skills: Exceptional written and verbal communication skills, with the ability to articulate complex information clearly to a variety of audiences, from investigators to senior executives.
Problem-Solving: A proactive and solutions-oriented mindset, capable of navigating ambiguity and resolving complex operational hurdles.
Negotiation & Conflict Resolution: Adept at negotiating with vendors and internal stakeholders, and skilled in resolving conflicts constructively.
Adaptability & Resilience: Thrives in a fast-paced, dynamic environment and demonstrates resilience in the face of setbacks or changing priorities.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s Degree

Preferred Education:

Advanced degree (MSc, PhD, PharmD, MBA) in a relevant scientific or healthcare field.

Relevant Fields of Study:

Life Sciences (Biology, Chemistry, etc.)
Nursing (BSN, RN)
Pharmacy or Health Sciences

Experience Requirements

Typical Experience Range: 5-8+ years of progressive experience in clinical research within the pharmaceutical, biotech, or CRO industry.

Preferred: A minimum of 3-5 years of direct, hands-on experience in a lead role managing multi-center, global clinical trials. Demonstrable experience managing a study from start-up through to database lock and CSR is highly desirable. Experience across multiple therapeutic areas is a significant asset.