The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Global Clinical Study Manager based in the United States.
This role leads the end-to-end delivery of global clinical studies, from feasibility and planning through closeout. You will coordinate multidisciplinary teams and external partners to ensure studies meet timelines, quality standards, and budget expectations. The position offers the opportunity to play a central role in advancing clinical research within a highly collaborative, global environment. You will oversee operational planning, risk management, vendor performance, study documentation, and inspection readiness. The role requires close collaboration with clinical operations, data management, medical writing, regulatory stakeholders, finance, and other functional experts. You will also help identify operational risks, drive continuous improvement, and ensure robust execution across regions and study sites. This is an impactful opportunity for an experienced clinical research professional who enjoys leading complex global programs and delivering results in a patient-focused environment.
Accountabilities
- Lead all aspects of assigned global clinical studies from feasibility and study planning through execution, closeout, and completion of the Clinical Study Report.
- Lead global cross-functional Clinical Study Teams, facilitate effective decision-making, and act as the primary escalation point for study-related issues.
- Coordinate and oversee external vendors and regional subject matter experts involved in study delivery.
- Build productive relationships with stakeholders across regions and functions and provide regular study updates to senior leadership.
- Develop, maintain, and communicate high-quality study timelines while monitoring progress against key milestones.
- Partner with clinical program leadership to assess trial feasibility, study allocation, site selection, and operational readiness across regions.
- Ensure study documents are available on time and meet quality standards for regulatory authority and ethics committee submissions.
- Oversee study start-up, site activation, project management plans, monitoring plans, Trial Master File plans, data monitoring plans, and other essential study documentation.
- Ensure clinical trial systems and tools are implemented correctly, maintained, and updated throughout the study lifecycle.
- Implement risk-based quality management processes, including periodic reviews, centralized monitoring analyses, and follow-up actions.
- Ensure study-specific training is developed, delivered, documented, and maintained appropriately.
- Maintain Trial Master Files according to established quality-control requirements and inspection-readiness standards.
- Collaborate with clinical supply teams to forecast study drug requirements and support timely delivery to sites.
- Support and, when needed, lead data-cleaning activities in collaboration with Data Management, clinical operations, and monitoring teams.
- Coordinate the planning and execution of Clinical Study Reports with Medical Writing and relevant study team members.
- Monitor study activities for compliance with protocols, SOPs, study plans, ICH/GCP requirements, and applicable regulations.
- Monitor quality metrics, identify risks and issues, and ensure corrective and preventive actions are implemented effectively.
- Maintain continuous inspection readiness and prepare study teams for quality audits and regulatory inspections.
- Share cross-functional and site-level learnings and best practices while driving initiatives that improve study efficiency and quality.
- Contribute to the development, optimization, and review of clinical operations procedures, work instructions, and SOPs.
- Partner with sourcing teams to select and manage vendors and oversee invoice approvals throughout the study.
- Manage study budgets, including baseline evaluations, change controls, forecasts, accruals, and study closure activities.
- Identify study resource requirements, monitor resource utilization, and establish contingency plans for critical resources.
- Ensure studies are delivered within approved timelines, quality expectations, and cost parameters.
- Bachelor’s degree in a scientific or healthcare-related discipline required; an advanced degree is preferred. Candidates with substantial relevant clinical operations experience may be considered for exceptions.
- At least 6 years of progressive clinical research experience within the biotechnology, pharmaceutical, or CRO industry.
- Proven project management experience leading global clinical studies; oncology experience is preferred.
- Demonstrated ability to independently lead complex global clinical studies across multiple regions and functions.
- Advanced knowledge of clinical operations methodologies and a comprehensive understanding of clinical study processes.
- Strong experience managing study timelines, budgets, vendors, resources, quality requirements, and operational risks.
- Solid knowledge of ICH/GCP standards, clinical research regulations, study documentation, and inspection-readiness requirements.
- Proficiency with Microsoft Office, project planning applications, and clinical trial management systems.
- Strong analytical and data-analysis capabilities, with the ability to assess complex information and make sound decisions.
- Excellent communication and stakeholder-management skills, including the ability to provide clear updates and influence cross-functional teams.
- Strong leadership and collaboration skills, with a demonstrated ability to foster teamwork and build effective relationships across cultures and geographies.
- Highly organized, results-oriented, proactive, and comfortable managing multiple priorities in a changing environment.
- Demonstrated initiative, continuous-learning mindset, adaptability, and ability to embrace change.
- Strong financial awareness and experience managing clinical study budgets and resources.
- Commitment to patient-focused research, operational excellence, integrity, and high-quality clinical study delivery.
- Willingness to travel as required by business needs.
- Annual base salary range of $118,600–$158,600, with actual compensation determined by factors such as experience, skills, certifications, education, and work location.
- Eligibility for an annual bonus plan for non-commercial roles.
- Opportunity to receive discretionary equity awards and participate voluntarily in an employee stock purchase plan.
- Medical, dental, and vision coverage.
- 401(k) plan.
- Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
- Life insurance.
- Paid time off.
- Wellness benefits and programs.
- Remote work opportunity within the United States.
- Opportunities to work on global clinical research programs and collaborate with multidisciplinary teams across regions.
- Supportive environment focused on professional development, continuous learning, collaboration, and meaningful patient impact.
- Travel opportunities based on business needs.
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.
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