Senior Manager, Study Start Up - FSP

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, Study Start Up - FSP in the United States.

This role sits at the heart of global clinical study execution, driving end-to-end study start-up and site activation across Phase I–III and real-world evidence trials. You will act as a key connector between clinical operations teams, CRO partners, vendors, and investigative sites to ensure studies launch efficiently and meet critical timelines. The position plays a strategic role in early study planning, country and site selection, and data-driven feasibility modeling to support predictable trial delivery. You will also lead efforts to streamline start-up processes, reduce complexity, and improve activation speed across global programs. Working in a highly collaborative and fast-paced environment, you will influence operational decisions that directly impact study success and enrollment performance. This role combines strategic oversight with hands-on execution, requiring strong leadership in global clinical development operations. It is ideal for someone passionate about accelerating clinical research and improving patient access to therapies.

• Lead global study start-up and site activation activities across multiple clinical programs, ensuring alignment with timelines, milestones, and organizational objectives.
• Develop, implement, and oversee comprehensive study start-up plans in collaboration with CRO partners and internal clinical operations teams.
• Drive country and site selection, feasibility assessments, enrollment forecasting, and scenario planning using data-driven insights.
• Establish and optimize processes, tools, and methodologies to improve start-up efficiency and consistency across studies.
• Partner with cross-functional stakeholders and CRO teams to resolve site-level challenges and remove activation barriers.
• Track key performance indicators (KPIs), cycle times, and operational metrics to identify risks and improve delivery performance.
• Ensure compliance with global regulatory requirements, GCP standards, and internal quality expectations across all start-up activities.

Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline.
• 8+ years of experience in clinical operations within a CRO or biopharmaceutical environment.
• 5+ years of experience managing clinical study operational activities, ideally in global or multinational trials.
• Proven expertise in study start-up, site activation, feasibility, and country/site selection processes.
• Strong experience collaborating with CROs, external vendors, and cross-functional clinical teams.
• Solid understanding of GCP, clinical trial regulations, and study management processes.
• Excellent project management, analytical, and organizational skills with the ability to manage multiple priorities.
• Strong communication and leadership skills, with experience guiding teams and influencing stakeholders in a global setting.

Benefits:

• Competitive compensation package aligned with experience and market benchmarks.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plans with employer contribution options.
• Flexible work arrangements, including hybrid or remote opportunities depending on role requirements.
• Paid time off, holidays, and wellbeing leave policies.
• Professional development opportunities and access to global clinical research projects.
• Collaborative, mission-driven environment focused on advancing healthcare innovation.