Study Start-up Project Manager

Role Summary

This role is part of the Clinical Trial Accelerator Unit (CTAU) and is responsible for accelerating Study Start Up activities and ensuring all site activations are made on time in global clinical studies. The individual will harmonize processes and provide start-up expertise to assigned studies and programs, ensuring study teams meet or exceed Final Protocol to First Patient In timelines. The role involves strategic leadership and execution, quality compliance, risk management, performance monitoring and cross-functional collaboration.

Responsibilities

• Lead the strategy and execution of site activation activities for global clinical studies
• Develop and maintain critical path and timelines for site activation
• Oversee and negotiate timelines for Master Informed Consent Forms (ICFs), including country and site-level ICF creation.
• Ensure site activation activities are inspection-ready and compliant with ICH-GCP and Biogen SOPs
• Perform or delegate quality checks on submission and site essential documents
• Ensure timely and accurate submissions to ethics committees and regulatory authorities
• Conduct proactive risk assessments and guide mitigation planning
• Analyze metrics and KPIs to monitor performance and drive improvement
• Manage cross-functional collaboration and resource allocation to support study start-up.
• Lead departmental growth initiatives and champion adoption of SSU process improvement tools and templates

Qualifications

• Required: B.A. or B.S. in a scientific discipline; advanced degree preferred
• Required: 10+ years in Clinical Research with 5+ years in global clinical trial start-up
• Required: Previous experience in a CRO essential, preferably in a senior start-up role leading cross-functional teams and managing global SSU deliverables
• Required: Scientifically and clinically astute with very strong project management skills and skilled in planning, tracking milestones, and risk mitigation
• Required: Deep understanding of ICH-GCP, global and local regulatory requirements
• Required: Experience with IRB/EC submissions
• Required: Ability to lead and influence in a matrix environment - takes ownership of timelines and deliverables
• Required: Proactive mindset with ability to identify bottlenecks and propose solutions
• Required: Good organizational, time management, communication, and interpersonal skills
• Required: Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
• Required: Occasional travel required
• Preferred: Experience in Veeva and Microsoft Project