Senior Manager, Study Start Up – FSP

ManagerManagerFull TimeRemoteTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

31 days ago

Salary

Not specified

Bachelor Degree8 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. • Lead development of procedures to enhance internal start-up capabilities and drive efficiencies 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. • Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts. • Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning. • Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Startup Services. • 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 the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency.

Job Requirements

  • Bachelor’s Degree in Science or related discipline required.
  • Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies.
  • Considerable (5+ years) managing operational aspects of clinical studies.
  • Significant experience in leading global study start-up and site activation activities is required.
  • Must have experience working with external CROs and cross functional teams.
  • Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment.
  • Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.

Benefits

  • Health insurance
  • Retirement plans
  • Professional development

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