Manager, Study Start Up – FSP

ManagerManagerFull TimeRemoteTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

30 days ago

Salary

Not specified

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

• Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery. • Develop and deliver the global study startup plan by partnering with the CRO Study Startup team. • Drive efficiencies to enhance internal start-up capabilities to align with Trial Delivery Optimization goals. • Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals. • Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning. • Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines. • Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations. • Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks. • Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation. • Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements. • Build and maintain study start-up, country and site activation best practices. • Support inspection/audit readiness by ensuring compliance with GCP, SOPs, and regulatory requirements. • Contribute to continuous improvement initiatives, tool/technology adoption, and knowledge sharing to enhance study start-up efficiency.

Job Requirements

  • Bachelor’s Degree in Science or related discipline is required
  • 5-7 years of clinical research experience in a CRO or pharma organization, including direct involvement in leading global study start-up and site activation is required
  • Prior experience overseeing CROs on multinational clinical studies
  • Working knowledge and strong understanding of study start-up processes: feasibility
  • Knowledge of ICH/GCP, broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment
  • Excellent organizational, communication, and problem-solving skills with proven ability to manage competing priorities
  • Demonstrated ability to build strong relationships with CROs, vendors, and cross-functional partners

Benefits

  • Pay equity and transparency
  • Employee development programs
  • Learning and training opportunities

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