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Manager, Global Clinical Monitoring

44 minutes ago
United States
Full-time
Lead
Operations Manager
Operations
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 135

Description

  • Lead, manage, and motivate CRA staff to support quality standards and team performance.
  • Develop action plans and provide strategic oversight to optimize CRA services and departmental goals.
  • Support project resourcing by assigning appropriate CRA coverage and maintaining tracking systems.
  • Collaborate with Clinical Team Leads, Clinical Trial Managers, and Clinical Operations Management on site and resource needs.
  • Mentor, coach, and develop CRAs to strengthen skills, accountability, and career progression.
  • Conduct accompanied site visits to assess CRA performance and provide project-specific support.
  • Identify quality risks and performance issues and recommend corrective action plans to leadership.
  • Ensure staff have the resources, training, materials, and system access needed to perform their roles.
  • Maintain CRA administrative updates in company systems, including SOPs and time and expense reporting.
  • Develop and evaluate CRA oversight metrics and support continuous improvement initiatives.
  • Participate in hiring activities, including CV review and interviews for new CRAs.
  • Support onboarding and training for new CRA staff with HR, Clinical Training, and other functions.

Requirements

  • Graduate, postgraduate, 4-year college degree, or equivalent experience, ideally in a scientific or healthcare discipline.
  • At least 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 development programs for clinical staff.
  • Experience developing evaluation processes, performing gap analysis, and ensuring staff are trained to quality standards.
  • Ability to drive and travel domestically and internationally, including overnight stays, approximately 25% of the time.
  • Mastery of ICH-GCP, applicable local regulatory requirements, Precision for Medicine SOPs, and regulatory guidance.
  • Preferred experience in the therapeutic area or country of the assigned staff.

Benefits

  • Competitive salary range of $121,800 to $182,600 USD.
  • Eligible for a discretionary annual bonus.
  • Health insurance, retirement savings benefits, life insurance, and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
  • Equal Opportunity Employer policies and accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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