Senior Global Clinical Study Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Global Clinical Study Manager based in United States.

The Senior Global Clinical Study Manager will lead the successful execution of complex international clinical studies, ensuring delivery within timelines, budget, quality, and regulatory expectations. This role offers the opportunity to drive impactful oncology research by coordinating global cross-functional teams, managing external partners, and advancing clinical programs that improve patient outcomes. The position requires a strategic and operational mindset, combining deep clinical expertise with strong leadership and project management capabilities. Working in a collaborative, science-driven environment, you will influence study strategy, optimize processes, and ensure inspection readiness throughout the clinical trial lifecycle. This is an opportunity for an experienced clinical operations professional to make a meaningful contribution to global healthcare innovation.

Accountabilities:: The Senior Global Clinical Study Manager is responsible for overseeing all aspects of assigned global clinical studies, from planning and feasibility through closeout, while ensuring operational excellence, compliance, and successful collaboration across internal and external stakeholders.

Lead global cross-functional clinical study teams, ensuring effective decision-making, alignment on objectives, and timely resolution of study-related challenges.

Manage external vendors and partners involved in study execution, ensuring performance, quality, and adherence to agreed deliverables.

Develop and maintain comprehensive study plans, timelines, milestones, risk assessments, and operational strategies across global regions.

Oversee clinical trial execution, including site selection, activation, enrollment support, monitoring activities, data cleaning, and study closeout.

Ensure clinical studies remain compliant with protocols, SOPs, ICH/GCP guidelines, regulatory requirements, and internal quality standards.

Drive risk-based quality management processes, identify potential issues, and implement mitigation and corrective action plans.

Maintain inspection readiness by ensuring accurate documentation, Trial Master File quality, audit preparation, and regulatory compliance.

Partner with cross-functional teams including clinical operations, data management, medical writing, clinical supplies, finance, and regulatory stakeholders.

Support continuous improvement initiatives by developing processes, work instructions, SOP enhancements, and operational best practices.

Manage study budgets, resource planning, vendor payments, forecasting, and financial reporting to ensure delivery within approved parameters.

Mentor junior team members and contribute to the development of clinical study management capabilities.

Requirements:

The ideal candidate brings extensive experience in global clinical research, strong leadership capabilities, and a proven ability to manage complex clinical programs within biotech, pharmaceutical, or CRO environments.

Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred.

7+ years of progressive experience in clinical research, clinical operations, or global study management within biotechnology, pharmaceutical, or CRO organizations.

Proven experience independently leading global clinical studies from feasibility through completion.

Strong project management expertise with demonstrated ability to manage timelines, budgets, resources, and cross-functional teams.

Advanced knowledge of clinical operations processes, clinical trial methodologies, regulatory requirements, and ICH/GCP standards.

Oncology clinical study experience preferred.

Experience managing external vendors, clinical trial systems, and global study technologies.

Strong understanding of risk management, quality oversight, inspection readiness, and regulatory compliance practices.

Excellent communication, stakeholder management, problem-solving, and decision-making skills.

Ability to collaborate effectively across global, multicultural, and matrixed teams.

Proficiency with MS Office, project planning applications, and clinical trial management systems.

Willingness to travel as required by business needs.

Benefits:

Competitive annual salary range of $136,400 – $181,400 USD .

Eligibility for annual bonus opportunities.

Opportunity to receive discretionary equity awards and participate in an employee stock purchase program.

Comprehensive healthcare coverage, including medical, dental, and vision plans.

401(k) retirement plan with available company contributions.

Flexible spending and health savings account options.

Life insurance and wellness programs.

Paid time off and employee support programs.

Opportunity to contribute to innovative global healthcare solutions focused on improving patient access and outcomes.

Collaborative, mission-driven environment with opportunities for professional growth and continuous learning.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1