Director, Clinical Study Management

Responsible for providing leadership and oversight to support the global activities and timelines related to execution of full-service clinical trials, including oversight of project management and project finance teams. As part of the senior leadership team, participate in the development and implementation of organizational strategies, technologies and best practices that ensure superior customer service, staff development, quality information management reporting and effective, efficient divisional short- and long-term goals that align with the organization's vision, mission, and direction.

Role includes policy and process development and improvement, product quality, compliance monitoring, staff resource planning, staff, and contractor performance management. To provide support, expertise and represent project and finance teams with sponsors/clients throughout the project life cycle. Ensure all team members deliver high quality, timely service and that service delivery processes are maintained in accordance with corporate and industry best practices that meet all regulatory requirements and guidelines.

Support Business Development by assisting with bid development and defense as required.

• As part of the senior management team, participates in the operational planning process identifying and advocating on behalf of the functional area and the stakeholders it supports.
• Guides the departmental planning and implementation process to transform strategic plans and direction into measurable operational short‑ and long‑term goals and targets.
• Oversee and/or participate in the project development process working with Sponsors and functional Directors to negotiate and deliver quality product(s), assessing resource and financial and safety requirements, assigning resources, overseeing trial conduct, information, and data confidentiality, and supporting project teams by assisting the troubleshooting and resolution process while ensuring all align with corporate objectives.
• Responsible to ensure sufficient project level staffing and maintain utilization targets.
• Represent project operations on cross‑department planning initiatives.

• Serve as a role model, motivator, and mentor to members of the Clinical Project Operations team ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to managers and/or leaders in the areas of work allocation, resource planning, staff allocation, training and development, employee engagement, team development and performance management (staff evaluation, performance improvement and lost time management).
• Acts as senior representative of project operations team at client meetings.
• Represent project operations at business development meetings including but not limited to bid defenses, general capabilities, and scientific conferences.
• Attend and present at investigator meetings as needed.

• Works in collaboration with leadership team to achieve excellence in project services, evaluating and implementing recommendations to minimize organizational risk, meet all regulatory and/or industry standards, while creating and promoting programs that support the Organization's growth as a world class provider of clinical research and research services.

• Working in conjunction with members of the senior leadership team to plan, manage, advocate and report on behalf of the department during the budget and annual operational review processes.
• Maintain knowledge of financial and regulatory risks and requirements related to department service delivery and direct the development of methodologies to review, monitor, and manage risks and requirements.
• Work in conjunction with business development to prepare budgets and proposal text in response to requests for proposal, requests for information and statements of work.
• Oversee change order development for full‑service projects ensuring realization of project costs are achieved in line with work performed.