Manager, Clinical Operations Site Management - Rare Disease (Remote anywhere in U.S.)

Location: Morrisville, North Carolina, United States

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Requisition Number: 1108

Position Title: Senior Manager, Clinical Operations Site Management (Franchise Lead)

External Description:

The Site Management Franchise Lead - Rare Disease is responsible for providing on-time and quality delivery of site management services from assigned Clinical Research Associates within General Medicine and Rare Disease.

RESPONSIBILITIES:

  • Provide therapeutic and operational expertise throughout the program/project delivery lifecycle
  • Ensure that projects within the Franchise are properly resourced
  • Responsible for creating-collaborating with Therapeutic team to provide effective delivery strategies and solutions for Franchise projects and programs
  • Act as main contact person for the Project management Franchise Lead
  • Present at Proposal Defense/client meetings as needed to support new or ongoing business
  • Ensure CRAs are trained on project specifics
  • Ensure LCRAs are trained to support the clinical scope of work (which includes SOP review, QI/CAPA understanding, Clinical Monitoring Plan)
  • Coordinate and collaborate, with WCT Global Quality Assurance, to provide training opportunities identified in CAPA information
  • Manage the quality of assigned staff's clinical work
  • Coordinate efforts between the Project Management, Site Management, and Study Start Up
  • Establishing regular communication to include quality metric (SVR compliance, SDV metrics, on site metric discussion, etc.) and overall “health” of the projects (data query status, managing to the SOW, resource status)
  • Conduct appraisal performance review for direct reports

REQUIREMENTS:

  • Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and eight years of clinical research experience as a clinical research associate 
  • Two years more management experience
  • Extensive experience in General Medicine and Rare Disease is required, Oncology experience is a plus
  • Travel required
  • Passport required

 #L1-KC1

#LI-Remote

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Manager, Clinical Operations Site Management - Rare Disease (Remote anywhere in U.S.)

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.

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