Clinical Operations Manager - United States

Location: United States

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Requisition Number: 2616

Position Title: Manager, Clinical Operations Site Management

External Description:

The Manager, Clinical Operations Site Management is responsible for providing management of assigned Clinical Research Associates. This includes, but is not limited to, ensuring CRAs’ work effectiveness, optimal utilization and performance.

This is a home-based position which may be based anywhere in the continental United States.
Tasks may include but are not limited to:

  • Responsible for interviewing and hiring Clinical Research Associates (CRA)
  • Onboarding of permanent and contracts CRAs
  • Ensure CRAs are properly and timely trained to perform all types of visits as well as other billable monitoring activities
  • Provide on-site mentoring for CRAs thorough observation or site assessment visits
  • Establish regular communication and 1:1 calls with CRAs to review and discuss quality metrics (SVR compliance, SDV metrics, TMF readiness, Expense reports submissions, project status, etc.)  
  • Act as point of escalation for CRA performance issues on projects
  • Review Time Cards including review and approval of hours billed by contractors
  • Review the accuracy of Sciforma assignments and workload
  • Conduct performance appraisals, rewarding and disciplining employees, addressing employee relations issues and resolving problems
  • Write and conduct CAPAs when necessary
  • Review and approve CRA non-billable expenses


  • Ability to understand multiple study protocols
  • Superior oral and written communication skills
  • Strong planning and organizational skills
  • Good interpersonal skills
  • Experienced problem solving/decision making skills
  • Attention to detail
  • Understanding of clinical research principles and process, data collection and editing skills
  • Ability to navigate in EDC software (InForm, Medidata, etc.)
  • Strong knowledge of FDA regulations, ICH Guidelines and HIPAA
  • Understanding of standard operating procedures
  • Knowledge of therapeutic areas
  • Knowledge of Word, Excel and Outlook


  • Requires a bachelor’s degree or a two-year nursing degree
  • 8+ years’ experience as a clinical research associate
  • 2+ years’ direct management experience
  • Travel required
  • Passport required




State: North Carolina

Employment Type: Regular

Community / Marketing Title: Clinical Operations Manager - United States

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.



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