Director, Clinical Study Management

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

Lead global clinical study operations within a specialized clinical research environment focused on advancing treatments for gastrointestinal diseases. In this senior leadership role, you will oversee clinical project management and project finance teams, ensuring the successful delivery of complex, full-service clinical trials. You will translate organizational strategy into operational priorities while driving quality, efficiency, financial performance, and regulatory compliance. Working closely with senior leaders, sponsors, clients, and cross-functional teams, you will shape service delivery and strengthen organizational capabilities. You will also play a key role in developing talent, optimizing resources, and supporting business development initiatives. This is an opportunity to influence global clinical research operations while contributing to scientific progress and meaningful patient outcomes.

As a member of the senior leadership team, you will provide strategic and operational direction for clinical study management, overseeing project delivery, financial performance, team development, and service excellence. Your responsibilities will include:

• Operational planning and oversight:

  • Contribute to senior-level operational planning, representing departmental priorities and stakeholder needs.

  • Translate strategic objectives into measurable short- and long-term operational goals, plans, and performance targets.

  • Oversee the development and execution of full-service clinical trials in collaboration with sponsors and functional leaders.

  • Evaluate project requirements, including staffing, financial resources, timelines, and safety considerations, and ensure appropriate resource allocation.

  • Monitor trial execution, data and information confidentiality, and project performance while supporting teams in resolving operational challenges.

  • Maintain adequate project staffing levels and ensure resource utilization targets are achieved.

  • Represent clinical project operations in cross-functional planning and organizational initiatives.

  • Unit leadership and team management:

    • Lead, motivate, mentor, and develop Clinical Project Operations teams, ensuring functional areas have appropriately qualified and trained personnel.

    • Support managers and team leaders with workload distribution, resource planning, staff allocation, training, employee engagement, and performance management.

    • Oversee staff evaluations, performance improvement initiatives, and lost-time management.

    • Represent project operations in sponsor and client meetings throughout the clinical trial lifecycle.

    • Participate in business development meetings, bid defenses, capability presentations, and scientific conferences.

    • Attend and present at investigator meetings when required.

    • Service quality and excellence:

      • Collaborate with senior leadership to continuously improve clinical project services and operational practices.

      • Evaluate and implement initiatives that reduce organizational risk and ensure compliance with applicable regulatory requirements and industry standards.

      • Promote quality, efficiency, and consistent service delivery to support the organization's development as a leading clinical research services provider.

      • Contribute to policy, process, and best-practice development across the department.

      • Budget planning and financial risk management:

        • Participate in departmental budgeting, annual operational reviews, and financial planning in collaboration with senior leadership.

        • Monitor financial and regulatory risks associated with service delivery and establish appropriate risk review and management methodologies.

        • Partner with Business Development to prepare budgets and proposal content for requests for proposals, requests for information, and statements of work.

        • Oversee change order development for full-service projects, ensuring project costs are appropriately recovered in line with work performed.

        • Monitor financial performance and provide clear reporting to support informed operational decisions.

        Requirements

        The ideal candidate is an experienced clinical operations leader with a strong background in full-service clinical project management, financial oversight, and global team leadership. You should bring:

        • A bachelor's or honors bachelor's degree from an accredited university and at least 10 years of relevant experience, training, and continued professional development; alternatively, a college diploma or degree with at least 15 years of related experience.

        • Extensive experience leading full-service clinical project management operations.

        • A proven ability to lead, coach, and develop teams while promoting high standards of quality and operational excellence.

        • Significant financial resource management experience, including participation in budget setting, expenditure and revenue decisions, financial processing, reconciliation, and reporting.

        • Experience overseeing complex clinical trial delivery, including project planning, resource allocation, timelines, and financial performance.

        • Strong understanding of clinical research operations, regulatory requirements, industry standards, and operational risk management.

        • Experience working with sponsors and clients throughout the clinical project lifecycle.

        • Ability to contribute to business development activities, including proposal preparation, budget development, and bid defenses.

        • Strong strategic planning, organizational, and problem-solving skills.

        • Excellent communication and stakeholder management capabilities, with the ability to influence senior leaders and guide cross-functional teams.

        • A commitment to staff development, employee engagement, continuous improvement, and high-quality service delivery.

        Benefits

        • Annual salary range of €112,000–€149,500.

        • Education reimbursement program for eligible full-time employees.

        • Monthly cell phone and remote work allowance, subject to role eligibility.

        • One-time office setup allowance for eligible equipment and furniture.

        • Working While Visiting program, allowing up to four weeks of work from another location per year.

        • Flexible summer hours from May through September.

        • Employee referral incentive program.

        • Eligibility to become a beneficiary of the employee trust after one year of employment, with permanent membership after five years.

        • Optional formal mentorship program.

        • Annual in-person social events organized by country or region.

        • Leadership development programs for people managers, tailored to seniority.

        • Social committee and additional voluntary initiatives designed to encourage connection and engagement.

        • Additional benefits may be available depending on the country of employment and applicable local policies and eligibility.

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!

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