Study Start-Up Manager: Global Site Activation & Budgets

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 139,000 - 163,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an experienced Manager to oversee feasibility, site startup, and budget negotiations to support our oncology clinical programs from our New Jersey/US operations.

You will partner with Clinical Operations, Legal, and Finance to drive activations, manage vendor relationships, ensure regulatory compliance, and deliver timely, cost-efficient trial start-ups across global studies.

Qualifications

• Minimum 5–7 years for manager level; 10+ years for Sr. Manager, with feasibility, study start-up, site agreements and eTMF in biotech or pharmaceutical setting.
• Must have knowledge of clinical trial conduct, including multi-center, global trials.
• Experience in working cross functionally and with external providers.
• Strong negotiation and contract management skills.
• Proficient user of MS Office suite and electronic document management systems.

Responsibilities

• Manage day-to-day SSU operations to ensure goals are met in compliance with GCP/ICH guidelines and regulatory requirements.
• Negotiate and finalize site agreements, including budgets, contracts, and documentation.
• Provide accurate project status and financial information within tracking systems/tools.
• Present budget details to senior leaders for approval and collaborate with Clinical and Finance on forecasts.
• Collaborate with legal, finance, CROs and clinical teams to ensure contracts comply with regulatory and company standards.
• Provide oversight to team members and develop SSU strategy during study start-up.

Skills

feasibility

study start-up

site budgets

contract negotiation

budget development

vendor management

GCP/IHC knowledge

Education

Life Sciences degree

Business Administration degree

Tools

MS Office

eTMF systems

Contract management software

Job description

Summit Therapeutics Inc. is seeking an experienced Manager to oversee feasibility, site startup, and budget negotiations to support our oncology clinical programs from our New Jersey/US operations.

You will partner with Clinical Operations, Legal, and Finance to drive activations, manage vendor relationships, ensure regulatory compliance, and deliver timely, cost-efficient trial start-ups across global studies.