Senior Manager, Clinical Trial

Description

• 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 assigned SSU staff or CRO partners, ensuring efficient delegation and oversight of start-up deliverables.
• Apply strategic insight and in-depth knowledge of start-up operations to identify and communicate risk to study, country or site start up, and implement solutions that align with broader clinical program goals.
• Oversee CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards.
• Regularly interact with cross-functional peers and leadership, influencing decision-making and gaining alignment on complex or sensitive matters and building collaborative relationships.
• Provide expert 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 regularly to CTWG and SSU leadership, including status updates, KPI tracking, risk mitigation, and issue resolution.
• Lead or contribute to functional 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

• 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.
• Recognized as a subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.
• Demonstrated experience establishing and managing work plans, performance metrics, and budgets for study start-up in both in-house and outsourced operating model.
• Proven ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings.
• Proficiency in clinical systems (e.g., CTMS, eTMF, Veeva Vault) and reporting tools.
• Excellent communication, leadership, and stakeholder management skills.
• Experience supporting audits and regulatory inspections related to start-up activities.
• Ability to influence and collaborate across functional teams while maintaining positive working relationships.