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.

Accountabilities:

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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Senior Manager, Study Start Up - FSP

Requirements:

Benefits:

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