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Manager, Global Clinical Monitoring

41 minutes ago
United States
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 137

Description

  • Lead, manage, motivate, and develop CRA staff, including employee and consultant resources.
  • Oversee CRA resource planning and allocation to ensure projects are appropriately staffed by phase and need.
  • Collaborate with Clinical Team Leads, Clinical Trial Managers, and Clinical Operations leadership to meet resource and site requirements.
  • Create action plans and provide strategic oversight to improve CRA services and delivery of team and department goals.
  • Coach and mentor CRAs through site visits, performance feedback, and career development support.
  • Identify quality risks and performance issues, and recommend corrective action plans to leadership.
  • Ensure staff have the training, tools, materials, and system access needed to perform their roles effectively.
  • Review and ensure timely completion of required administrative documentation, including SOPs and travel and expense reporting.
  • Develop and maintain metrics for CRA resource oversight and evaluate those metrics with clinical operations leadership.
  • Participate in hiring activities, including CV review, interviews, and onboarding training for new CRA staff.

Requirements

  • Graduate, postgraduate, or 4-year college degree, or equivalent experience, ideally in a scientific or healthcare discipline.
  • 7+ years of experience in clinical operations, data management, or a related discipline in CRO or pharmaceutical industry.
  • Minimum 5 years of onsite monitoring experience.
  • Experience using electronic data capture systems and both paper and electronic medical records.
  • 3-5 years of direct supervisory experience managing CRAs.
  • Experience creating effective development programs for clinical staff.
  • Experience developing evaluation processes, performing gap analysis, and ensuring clinical staff are trained to Precision for Medicine quality standards.
  • Ability to drive and travel domestically and internationally, including overnight stays, approximately 25% of the time.
  • Preferred experience in the therapeutic area and/or country of the staff being managed.
  • Strong working knowledge of ICH-GCP, local regulatory requirements, Precision for Medicine SOPs, and clinical trial methodology.

Benefits

  • Competitive salary range of $121,800 to $182,600 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance coverage.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.

Interested in this position?

Apply directly on the company website

Apply Now

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