Senior Manager, Site Start Up

Accountabilities:

The Senior Manager, Site Start Up is responsible for overseeing and advancing study start-up activities for outsourced clinical trials, ensuring successful site activation while maintaining compliance, quality, and operational excellence. The role requires strong project leadership, stakeholder management, and the ability to navigate complex regulatory and country-specific requirements.

• Lead oversight of site start-up activities across assigned clinical trial programs, ensuring milestones, timelines, and deliverables are achieved.
• Develop, review, and approve study start-up plans, defining tasks, timelines, processes, and responsibilities from project initiation through activation.
• Partner with CRO teams and internal stakeholders to monitor progress, identify risks, and implement mitigation strategies to maintain study timelines.
• Act as the primary point of contact for start-up-related activities, communicating challenges, solutions, and updates effectively across project teams.
• Coordinate with Clinical Trial Managers, Regulatory, Legal, Contracts, and Clinical Operations teams to ensure seamless execution of site activation activities.
• Apply strong knowledge of regional and country-specific start-up requirements, regulatory landscapes, and operational processes.
• Monitor CRO performance, evaluate delivery against plans, and drive continuous improvement in start-up execution.
• Support matrix project leadership by coordinating regional activities and ensuring alignment across global teams.
• Provide guidance, mentorship, and knowledge sharing to junior team members to strengthen start-up capabilities.
• Contribute to process improvements, inspection readiness, and operational excellence initiatives within clinical development programs.

Requirements:

The ideal candidate brings extensive experience in clinical research operations, particularly within global clinical trials and site start-up environments. They should have strong project management capabilities, excellent communication skills, and the ability to collaborate effectively with internal and external partners.

• Bachelor’s degree in Life Sciences, Healthcare, or a related field, or equivalent professional experience gained through relevant industry experience.
• Extensive experience within the pharmaceutical, biotechnology, CRO, or clinical research industry.
• Previous experience working in clinical trial start-up, clinical trial management, clinical trial coordination, or similar global study roles.
• Strong understanding of clinical operations, clinical processes, medical terminology, and global trial execution.
• Excellent knowledge of Good Clinical Practice (GCP), regulatory requirements, and inspection readiness expectations.
• Experience managing CRO partnerships, outsourced clinical activities, and complex stakeholder relationships.
• Proven project management skills, including timeline management, risk identification, and process improvement.
• Ability to analyze challenges, develop solutions, and operate effectively in a fast-paced, deadline-driven environment.
• Strong interpersonal and communication skills, with the ability to influence teams across different functions and regions.
• Experience mentoring or developing junior team members is preferred.
• Experience supporting regulatory inspections and knowledge of controlled drug substance processes is considered an asset.

Benefits:

• Competitive salary package based on skills, experience, qualifications, and market factors.
• Fully remote work opportunity with flexibility across eligible locations.
• Comprehensive benefits package for eligible employees.
• Opportunities to contribute to global clinical research programs with meaningful patient impact.
• Professional development opportunities and career growth within a global healthcare environment.
• Collaborative culture focused on innovation, teamwork, and improving health outcomes.