Senior 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.
• 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.

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.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement plans
• Professional development