Global Clinical Study Senior Manager in New York at Jobgether

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 Senior Manager based in the United States.

This is a senior clinical operations leadership role responsible for the end-to-end delivery of global clinical studies.
You will oversee study execution from start-up and feasibility through enrollment, ongoing operations, and close-out.
The role requires strong coordination across regional clinical teams and functions including Medical, Regulatory, Biometrics, Supply, and other stakeholders.
You will drive performance against timelines, enrollment goals, quality standards, budgets, and operational milestones across multiple regions.
As a key study leader, you will proactively identify risks, resolve escalated issues, and ensure consistent execution while allowing for regional needs.
The position combines strategic oversight with hands-on operational leadership in a collaborative, globally distributed environment.
It is an opportunity to shape study strategy, strengthen operational processes, mentor colleagues, and contribute directly to high-quality clinical development.

• Lead the end-to-end operational delivery of one or more global clinical studies, maintaining accountability for timelines, enrollment, quality, budget, and overall execution.
• Lead global clinical operations teams and provide direction to regional clinical study managers, ensuring clear roles, responsibilities, decision-making, and accountability.
• Act as a primary escalation point for operational issues and drive timely resolution in collaboration with regional and cross-functional stakeholders.
• Develop and execute study start-up strategies, enrollment acceleration plans, site activation plans, and other critical operational deliverables.
• Plan and manage clinical studies from feasibility through close-out in alignment with global study timelines and regional requirements.
• Drive trial feasibility, country allocation, and site selection in partnership with feasibility managers, country leadership, Medical Affairs, and other stakeholders.
• Maintain high-quality start-up and recruitment timelines based on regional input and continuously track progress against milestones.
• Coordinate the timely availability of global study documents, including informed consent materials, to support regulatory and ethics submissions.
• Ensure study information is accurate and current across relevant systems, tools, and documentation.
• Collaborate with CRAs and regional teams to support effective site execution and review and approve monitoring reports as appropriate.
• Oversee the creation, maintenance, and quality control of country- and site-level Trial Master File documentation in accordance with established QC plans.
• Partner with Clinical Supplies and other teams on drug inventory, local labeling, comparator drug requirements, regulatory approvals, and reimbursement considerations.
• Manage regional data collection activities, including data entry and query resolution, and support Clinical Study Report planning and execution when required.
• Monitor study activities for compliance with protocols, SOPs, ICH/GCP requirements, and applicable regulations.
• Maintain inspection readiness throughout the study lifecycle and support preparation for audits, inspections, and responses to findings.
• Identify study risks and operational issues, assess their potential impact, communicate them to leadership, and implement effective mitigation strategies.
• Promote cross-functional learning, best practices, and continuous improvement across study teams.
• Lead or contribute to the development, optimization, and review of work instructions, SOPs, and global clinical operations tools.
• Own global study budget planning, tracking, and forecasting while ensuring resources are allocated effectively across regions.
• Partner with Finance, functional leaders, and sourcing teams to manage cost-performance trade-offs and select and oversee study vendors.
• Manage regional study budgets, investigator fees, site payment issues, patient travel reimbursement activities, and related operational processes.
• Assess resource requirements, monitor utilization throughout the study lifecycle, and develop contingency plans for critical resources.
• Represent study leadership in cross-functional reviews and provide clear, concise, and transparent updates on study status, risks, trade-offs, and mitigation plans.
• Mentor junior colleagues and support the onboarding of new team members.

• Bachelor’s degree in a scientific or healthcare discipline required; an advanced degree is preferred.
• More than 5 years of project management experience in clinical trials within the biotechnology, pharmaceutical, CRO, or related industry.
• Proven clinical research experience, including experience serving as a team lead within clinical functions.
• Demonstrated ability to lead global clinical study teams and coordinate complex activities across multiple regions.
• Strong understanding of clinical trial operations, study start-up, feasibility, site selection, enrollment, data collection, quality management, and study close-out.
• Experience managing clinical trial timelines, budgets, resources, vendors, and operational risks.
• Strong knowledge of applicable clinical research standards, including ICH/GCP and relevant regulatory requirements.
• Excellent cross-functional leadership and stakeholder management capabilities, with the ability to influence decisions and resolve complex issues.
• Strong analytical, organizational, project management, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to provide clear and transparent updates to senior stakeholders.
• Demonstrated ability to foster teamwork, provide and receive actionable feedback, act inclusively, and build effective relationships across geographically distributed teams.
• Results-oriented mindset with strong initiative, adaptability, continuous-learning orientation, and an entrepreneurial approach to problem-solving.
• Strong financial awareness and ability to evaluate resource and budget trade-offs.
• Proficiency with Microsoft Office and project planning applications.
• Ability and willingness to travel as required by business needs.

• Annual base salary: $136,400–$181,400, with actual compensation determined by factors including job-related skills, experience, certifications, education, training, and work location.
• Eligibility for an annual bonus plan for non-commercial roles.
• Opportunity for discretionary equity awards and voluntary participation in an Employee Stock Purchase Plan.
• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement benefits.
• FSA/HSA options.
• Life insurance coverage.
• Paid time off.
• Wellness benefits.
• Remote work opportunity within the United States.
• Opportunity to lead high-impact global clinical studies and collaborate with multidisciplinary teams across regions.
• Exposure to strategic clinical development initiatives, operational improvement, and global study leadership.