Study Start UP Oversight Lead

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 direction and execution, quality compliance, risk management, performance monitoring and cross-functional collaboration. You are a subject matter expert with deep expertise in clinical research and study start-up.

Responsibilities

• Lead and oversee the execution of site activation 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
• Take part in departmental growth initiatives and champion adoption of SSU process improvement tools and templates
• Managing relationships with some of our key start up vendors which could include language services providers, translation vendors and printing vendors

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 start-up
• Required: Previous experience in a CRO preferred.
• Required: Scientifically and clinically astute with very strong project management skills and skilled in planning, tracking milestones, and risk mitigation
• 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: A commitment to maintaining high standards of quality and compliance in all project-related activities
• Required: Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
• Required: Deep understanding of ICH-GCP, global and local regulatory requirements
• Required: Strong technical skills, familiarity with translation management systems
• Required: Occasional travel required
• Preferred: Experience with IRB/EC submissions