Senior Manager, Clinical Trial Study Start Up

Role Summary

The Senior Manager, Clinical Trial Study Start-Up is a subject matter expert in clinical study start-up responsible for leading the process that enables planning, coordination, and execution of study, country, and site-level start-up activities from site identification through to site activation. This role combines operational leadership with cross-functional collaboration, CRO oversight, and compliance with global regulatory and quality standards. The role establishes SSU objectives, delegates assignments appropriately, and resolves a range of operational issues, contributing strategic insight to optimize study delivery and potentially influencing key decisions across studies. This is the functional representative for SSU on the Clinical Trial Working Group (CTWG) for assigned trials.

Responsibilities

• Lead and manage end-to-end start-up activities for assigned clinical trials, including country/site activation strategies, country assessment and timeline input, regulatory submissions, essential document collection, and country and site readiness.
• Establish operational objectives and work plans for SSU staff or CRO partners, ensuring efficient delegation and oversight of start-up deliverables.
• Apply strategic insight and knowledge of start-up operations to identify and communicate risk to study, country or site start up, and implement solutions aligned with broader clinical program goals.
• Oversee CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards.
• Interact with cross-functional peers and leadership to influence decision-making, gain alignment on complex matters, and build collaborative relationships.
• Provide input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution.
• Serve as a key contact point for country and site start-up progress, reporting to CTWG and SSU leadership with status updates, KPI tracking, risk mitigation, and issue resolution.
• Lead or contribute to initiatives that improve startup methodology, quality, tools, and process efficiency across programs.
• Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions.

Qualifications

• Required: Recognized expertise in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.
• Required: Demonstrated experience establishing and managing work plans, performance metrics, and budgets for study start-up in both in-house and outsourced operating models.
• Required: Ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings.
• Required: Proficiency in clinical systems (e.g., CTMS, eTMF, Veeva Vault) and reporting tools.
• Required: Excellent communication, leadership, and stakeholder management skills.
• Required: Experience supporting audits and regulatory inspections related to start-up activities.
• Required: Ability to influence and collaborate across functional teams while maintaining positive working relationships.
• Preferred: Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Preferred: 5+ years of experience in operational clinical research, including 3+ years in study start-up operations and team leadership.

Education

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 5+ years of experience in operational clinical research, including 3+ years in study start-up operations and team leadership.

Skills

• Subject matter expertise in clinical site start-up and regulatory processes
• Strategic thinking and risk identification across study start-up activities
• Cross-functional collaboration and stakeholder management
• Budgeting, timelines, and performance metrics for start-up programs
• Proficiency with CTMS, eTMF, Veeva Vault, and related reporting tools
• Audit and regulatory inspection support experience