Sr. Manager, Study Start-Up

The Sr. Manager, Study Start-Up is responsible for overseeing and driving all global and regional activities related to clinicalstudy start up, site feasibility, site selection, contract and budget negotiations, and site activation. This role ensures timely,high-quality, and compliant study start-up deliverables to support the successful execution of clinical trials across theorganization’s portfolio. This role will implement the SSU skills development strategy, will build functional expertise across all regions and countries, manage a portfolio of site activation improvement initiatives, drive excellence in execution of siteactivation and manage external and internal customer’s expectations through the delivery of excellent solutions that ensureall milestones and quality targets are met.

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