Sr. Manager, Study Start-Up

Requirements

• The Sr. Manager, Study Start-Up will be responsible for the following:


Strategic Leadership
• Develop and implement global and regional strategies for efficient study start-up operations.
• Define key performance indicators (KPIs) to monitor progress, quality, and timelines.
• Lead and support geographic expansion of Study Start-up team; lead process improvement initiatives to streamline start-up activities.
• Estimate future resource requirements, create and support hiring plan.


Operational Management
• Support country selection, manage feasibility and site identification activities.
• Ensure site activation timelines are achieved according to study plans; proactively identify mitigation plans and review with project management in the event that plans are at risk.
• Supervise contract and budget negotiation processes.
• Monitor portfolio performance against site activation timelines and metrics (e.g., as defined by corporate objectives), while adhering to budget targets.


Business Development & Commercial Support
• Support country strategy for proposals, and creation of presentation materials for start-up strategy.


Team Management & Engagement
• Lead and mentor SSU team leads and specialists across regions.
• Build a high-performing team through training, coaching, and performance management.
• Foster collaboration between study start-up, regulatory, legal, project management, Site Engagement team and clinical operations.
• Efficiently manage allocations of study start-up staff which includes feasibility and document collection and frequently update resource algorithms based on portfolio needs.
• Provide strong leadership and management to the study start-up team, addressing escalated / recurrent issues, finding resolutions and mitigations, and continuously improving operational efficiencies of study start up activities.


Quality & Compliance
• Ensure all start-up activities adhere to ICH-GCP, regulatory guidelines, and internal SOPs.
• Support audits and inspections related to study initiation.

Qualifications

• Minimum 10 years related clinical operations experience, requirement for minimum 5 years of experience in overseeing start-up function & leadership
• BSc required in Life Sciences (advanced degrees preferred)
• Demonstrated experience in managing process improvement initiatives in Study Start-up.
• Proven experience managing global start-up teams and CRO partnerships.
• In-depth knowledge of global regulatory requirements and ethics submission processes.
• Excellent leadership, communication, and organizational skills.
• Strong problem-solving and decision-making abilities
• Proficiency in spoken and written English required