Manager, Study Start Up – FSP

Role Overview

• 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

Tech Stack

• Google Cloud Platform

Benefits

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