Manager, Study Start Up – FSP
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchstudy start-upsite activationfeasibilityclinical trial conductpatient retentionpatient recruitmentKPI trackingprocess improvementregulatory compliance
Soft Skills
organizational skillscommunication skillsproblem-solving skillsrelationship buildingcross-functional collaborationtime managementleadershipstrategic planningadaptabilityteamwork
Certifications
Bachelor’s Degree in Science