Clinical Operations Manager - United States

Location: Morrisville, North Carolina, United States

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This position is no longer posted.

Requisition Number: 619

Position Title: Senior Manager, Clinical Operations Site Management

External Description:

At Worldwide Clinical Trials we are the #UncommonCRO, with #UncommonTalent in CRAs & Project Managers. We have amazing people — smart, experienced, and united by a desire to change the course of medical science.

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.
 
RESPONSIBILITIES:
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

OTHER SKILLS AND ABILITIES:

  • 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

REQUIREMENTS:

  • 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

#LI-KC1

City:

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.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

 Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors

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© Worldwide Clinical Trials 2019

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.