Director of Clinical Operations

The Director of Clinical Operations is responsible for leading the operations of the company in the conduct of clinical research and clinical trials. The successful candidate will have management experience in the pharmaceutical, biotech or CRO industries. They will have a proven track record of success in managing operations, identifying and driving process improvements and efficiencies, and ensuring a consistent approach while mentoring a talented team of project managers.

Responsibilites

  • Supervise, manage and mentor a core group of project staff and take ownership of the quality of all project and client deliverables.
  • Ensure consistent practices and compliance with CRS procedures and policies throughout all phases of the project life cycle.
  • Apply project management best practices in development of project initiation, site start up, project planning, execution, control and close out. This includes but is not limited to establishing and setting project timelines, milestones and action items, determining project resources, developing internal and external status reports, identify operational issues and facilitating their resolution, and tracking and managing project schedules and status.
  • Plan and direct schedules and monitor budgets and spending.
  • Define metrics and implement measurement plan to evaluate project operation effectiveness.
  • Responsible for managing testing procedures for product releases and related assets (in coordination with Director of IT and other staff).
  • Develop and maintain positive and constructive client relationships, partnering with client’s team in a consultative role.
    • Deepen client relationships by effective and timely communication and soliciting formal, periodic feedback.
    • Identify areas of opportunity where CRS can add value to client’s operations and forward suggestions to the CRS sales team.
    • Address client issues and proactively drive resolution to the satisfaction of clients.
    • Lead client meetings and present study data to senior-level client executives.
  • Assist the CRS Financial team in corporate budget planning and CRS sales/business development in forecasting an operating budget.
  • Recruit and train project team members. Apply CRS corporate policies fairly and equitably across the team.
  • Evaluate individual project team member performance and ensure high levels of employee engagement and client service.
  • Participate as member of CRS Management team, leading by example.
  • Lead the team in process definition and SOP development efforts as it relates to CRS project management.
  • Identify and recommend additional product enhancement/customer support/process improvement opportunities with existing clients/studies.
  • Develop and refine expertise in the project management discipline, remaining current with industry best practices and incorporating them into CRS SOPs.
    • Lead the implementation of project management disciplines within the team.

Experience/Qualifications

  • Bachelors degree and 10+ years experience in Project Management, preferably in the Pharmaceutical/Biotech industry.
  • Previous experience in a Clinical Study environment and managing individuals is highly desirable and PMI certification is a plus.
  • Polished and professional presentation content and style, suited for senior executive management.
  • Proven ability to work in a team-oriented environment, providing leadership to team members and establishing/maintaining effective working relationships with co-workers within and across functional areas to encourage a positive team-oriented work environment.
  • Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects. (Samples of written communications will be requested)
  • Flexibility and an “all hands on deck” approach.
  • Ability to quickly learn and apply new skills, procedures and approaches.
  • Demonstrated ability to meet very short deadlines and multi-task in an extremely fast-paced work environment with little direct supervision.
  • Excellent organizational skills and the ability to apply extreme attention to detail and organization in all aspects of work.
  • Understanding of data management, statistics and medical writing processes.
  • Expertise in Microsoft Office (Word, Excel, Powerpoint).
  • Ability to occasionally travel nationally and internationally. Some travel does take place on/over weekends.

Resumés and cover letter may be submitted to hr@concordantrater.com.