Overview of Role:

The Senior Manager/Associate Director, Clinical Operations Site Partner (CSP), is accountable for providing leadership and operational expertise into execution of one or more phase 1-3 clinical trials conducted in a specific US region. The role will be part of the Global Clinical Operations (GCO) group reporting into USA Senior Director, Clinical Operations. This position is expected to address historic operational challenges in conducting clinical studies:

• Slow start-up timelines
• Site recruitment challenges
• Role designed to drive clinical trial strategy and execution while becoming industry leader
• Augment ClinOps study team (both Summit and CRO) activities to support study execution, including addressing any quality issues
• Development strategies to drive concierge level support for sites to ensure Summit journey to be Sponsor of Choice

Role and Responsibilities:

• Recommend oncology sites based on indication, community clinics requirements, etc.
• Engage investigators early on for feedback on protocol, design, recruitment rate, local practices, etc.
• Assist with feasibility questionnaire support (as needed)
• Maximize start-up efficiencies and expedite activation
• In-depth knowledge of site capabilities, and processes
• Attend SIVs and IMs as possible
• Provide concierge level support
• Motivate sites & identify obstacles quickly for resolution for recruitment challenges
• Tracking of key site performance metrics
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• BA/BS required; in a scientific/medical field preferred
• Previous CRA experience and / or regional manager in a CRO highly desirable
• A minimum of 8+ years industry or related experience
• Extensive late-stage drug development oncology experience is required
• Knowledge and experience of drug development in US
• Ability to travel up to 75%
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives
• Excellent written and verbal communication skills
• Proven ability to develop successful collaborations with internal and external partners

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.