Manager Clinical Operations


Direct clinical monitoring operations for a designated Quintiles regional office or group to ensure projects are appropriately resourced and employees are trained and developed to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. Lead strategic initiatives work with other functional management to develop implementation plans. Supervise Clinical Research Specialist (CRSs), Clinical Operations’ Associate Directors and/or Managers.


  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
  • Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process. Establish methods to develop and evaluate office/region based onboarding processes. Develop standard processes to ensure that staff has the proper materials, systems access and training to complete job responsibilities. Oversee the execution of the training plan, SOP review and mentored training experiences for a region/office/country.
  • Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with study team leadership and operational peers.
  • Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function. Evaluate regional workload, quality and budget metrics through regular review and reporting of findings. Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinical projects.
  • Act as a coach and mentor for lower level staff as they develop in their role. Works collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service.
  • Analyze and reviews budgets for clinical studies within region. Pro-actively plan for appropriate clinical operations budget consumption and guides line managers and CRSs in managing variances and in developing corrective fiscal action plans.
  • Conduct Clinical Project Review and participates in Project Management Review according to regional guidelines and interfaces with appropriate functional leadership to achieve positive outcomes.
  • Participate and may lead corporate or departmental quality or process improvement initiatives.
  • May act as a client liaison.


  • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods
  • Strong leadership skills
  • Effective presentation skills
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Strong written and verbal communication skills including good command of English
  • Excellent organizational and problem solving skills
  • Effective time management skills and ability to manage competing priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients


  • Bachelor’s degree in a health care or other scientific discipline or educational equivalent; 12 yrs of clinical trials experience including 7 years experience in a leadership capacity; or equivalent combination of education, training and experience”


  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Frequent travel, approximately 30-40% of work week

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