Senior Manager, Clinical Operations Site Partner (CSP)

Summit Therapeutics Sub, Inc.; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Clinical Operations to lead phase 1-3 clinical trials in a specific US region. This role involves addressing operational challenges and enhancing site recruitment strategies to ensure successful study execution. The ideal candidate will have extensive experience in late-stage drug development, particularly in oncology, and will play a critical role in fostering collaborations with investigators and managing site performance. If you are passionate about clinical research and want to make a significant impact in the field, this opportunity is for you.

Qualifications

• 8+ years of experience in clinical operations with a focus on oncology.
• Previous CRA or regional manager experience in a CRO is highly desirable.

Responsibilities

• Recommend oncology sites and engage investigators for protocol feedback.
• Maximize start-up efficiencies and track key site performance metrics.

Skills

Oncology expertise

Clinical trial management

Communication skills

Project management

Collaboration skills

Education

BA/BS in scientific/medical field

Job description

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Senior Manager, Clinical Operations Site Partner (CSP)

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
• 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