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Director, Study Start Up & Regulatory - Europe


Directs the development, implementation, and analysis of work within a specific or broad area of site start-up, such as site activation, regulatory/ethics submissions, site contracts, and/or post activation activities in one or multiple regions. Ensures fulfillment of customer requirements and compliance with related regulations. Analyzes processes and develops strategies to increase efficiency. Performs strategic and operational planning at the department or business unit level, including efficient allocation of resources within the department. Functional Profit/Loss (P/L) responsibility for assigned projects and strategic programs within the assigned departments and/or business unit. Contributes to the business development process and selling efforts by reviewing proposals and attending client meetings.


  • Provides guidance and approvals on people management on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
  • Directs processes, resourcing, and communications as the primary liaison and facilitator between customer leaders and senior management on related tasks and/or issues. Plans and negotiates resources with line management of functional areas. Plans for the efficient allocation of resources. Facilitates project reviews with staff, focusing on budget, schedule, and risk analysis of ongoing projects within Clinical Operations. Guarantees SSU delivery of assigned projects.
  • Maybe assigned as a senior SSU SME with allocated sponsor portfolio delivery oversight over sales, execution /delivery and operational performance evaluation. Direct deliverables on assigned client projects/programs to ensure that they are accomplished according to deadlines, business requirements and quality standards. Integrate the contributions of multiple SSU services. Serve in a team leadership/subject matter expert function as assigned and/or leads major accounts and most senior sponsor contact point, inclusive of strategy, escalation and portfolio governance.
  • Ensures continuous improvement of quality in all SSU and Regulatory components at the project level (submissions, essential document collection, communication to Competent Authority, Ethics Committees, site contracts, etc.).
  • Works with executive and senior management within the department or business unit to capture, develop, and present information for internal and management review meetings. Approves and supervises the implementation of training programs for appropriate departmental teams. Supervises and ensures all quality control efforts of departmental team leaders. Develops and supervises the reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times.
  • Supervises the escalation of issues to the Project Manager, senior management, or Legal Department. Identifies and reports areas of process and contract risk to executive management. Manages and reports operational risks of global departmental or business unit processes.
  • Drives the implementation of customer-required and/or enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems; may supervise systems implementation. May act as a business owner for a system. Reports on requirements for modifications to existing systems based on input from team leaders. Provides input and requirements for long-term IT plans.
  • Oversees the development and implementation of all processes using established process modeling techniques. Approves development of Company Standard Operating Procedures and Work Instructions related to area or that supports new or existing processes.
  • Develops and refines processes within the Company which lead to greater efficiencies or competitive advantages over other companies. May lead or participate in cross-company initiatives.
  • Qualifications


  • Bachelor’s Degree; Higher Degree Preferred
  • Extensive Clinical Trial experience
  • Significant experience managing teams of clinical research employees
  • Sales experience preferred
  • Strong knowledge of clinical research management processes
  • Understanding of the needs of countries and the ability to work across geographic regions
  • Strong CRO operational experience with a track record in project management working in an international or global capacity
  • Thorough knowledge of applicable regulations, drug development, and clinical project management procedures
  • Excellent leadership skills; ability to teach/mentor team members
  • Leads a team of employees to reach performance objectives
  • Strong ability to analyze data and make appropriate decisions
  • Excellent oral and written communication skills and strong presentation skills
  • Ability to motivate employees to define and reach team objectives
  • Ability to make difficult decisions under pressure and sometimes without all the information desired

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