Senior Manager, Clinical Site Partner (Italy)

Role Overview

The Senior Manager, Clinical Operations Site Partner (CSP) is responsible for providing leadership and operational expertise in the execution of one or more Phase I–III clinical trials across the European region.

As a key member of the Global Clinical Operations (GCO) group and reporting to the Senior Director, Clinical Operations (Europe), the Senior Manager CSP plays a pivotal role in ensuring operational excellence in trial conduct and site performance.

This position serves as the primary Summit operational point of contact for assigned clinical trial sites, with full accountability for the end-to-end lifecycle of studies. The role drives site selection, site start-up efficiency, accelerates site activation, recruitment, and maintains high standards of performance and quality throughout the study lifecycle.

The Senior Manager CSP acts as a strategic partner to sites and study teams—helping Summit achieve its vision of becoming a Sponsor of Choice by delivering a concierge-level experience to our clinical trial sites.

Key Responsibilities:

• Serve as the main operational contact for assigned clinical trial sites across Europe.
• Provide leadership and oversight for all operational aspects of site performance, from feasibility through study closeout.
• Recommend sites based on indication, experience, capabilities, and local knowledge.
• Engage with feasibility assessments and site selection activities.
• Involve sites early to gather feedback on protocol design, recruitment expectations, and local practices.
• Drive efficiency in study start-up and expedite site activation timelines.
• Maintain deep knowledge of site capabilities, processes, and requirements.
• Expertise in European clinical trial and country-specific regulations and guidelines.
• Act as a facilitator between Summit functions and site teams to ensure seamless communication and coordination.
• Participate in site visits, investigator meetings, and study-related interactions as required.
• Proactively identify and address obstacles impacting site recruitment and performance.
• Track key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions.
• Develop and deploy effective strategies to improve site engagement and performance.
• Deliver concierge-level support to sites, ensuring an optimal partnership experience.
• Contribute to continuous improvement initiatives within Clinical Operations.
• Perform all other duties as assigned.

Qualifications, Experience, and Skills

Education:

• Bachelor’s degree (BA/BS) in a scientific or medical discipline required.
• Advanced degree (MSc, PharmD, PhD) preferred.

Experience:

• Minimum of 8 years of industry experience in clinical research or related functions.
• Prior experience as a Senior Clinical Research Associate (SCRA) and/or Regional/Clinical Operations Manager within a CRO or sponsor organization highly desirable.
• Extensive late-stage oncology clinical trial experience required.
• Proven track record of operational excellence in multi-country clinical trial management.
• Strong understanding of drug development processes and regulatory environments in Europe.

Skills and Competencies:

• Excellent interpersonal, written, and verbal communication skills in Italian and English (additional European languages a plus).
• Exceptional organizational and planning abilities with demonstrated success in managing complex projects.
• Strong analytical and problem-solving skills, with the ability to anticipate challenges and develop pragmatic solutions.
• Understand and clearly articulate the development plan and strategic rationale.
• Ability to build effective partnerships with internal stakeholders, investigators, and external partners.
• Demonstrated leadership and influencing skills, with the ability to drive accountability and results.
• Comfortable working independently in a fast-paced, dynamic, and global environment.
• Willingness to travel up to 75% of the time within Europe and occasionally internationally.

Key Attributes for Success

• Strategic thinker with hands-on execution capability.
• Strong commitment to quality, timelines, and collaboration.
• Agile and proactive in addressing operational challenges.
• Passionate about advancing clinical research and improving patient outcomes.