Global Study Start-Up Manager – Oncology Trials

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 start-up, and budget negotiations for our Clinical Operations teams.

The role emphasizes strong relationships with clinical sites, CROs, and internal stakeholders to accelerate site activation and ensure regulatory compliance across global trials. The ideal candidate has extensive SA start-up experience, excellent negotiation skills, and the ability to manage multi-site budgets and timelines in a fast-paced

Qualifications

• 5–7 years experience for manager level, or 10+ years for Sr. Manager, with feasibility, study start-up, clinical trial site agreements and eTMF in biotech or pharmaceutical setting.
• Must have knowledge of clinical trial conduct, including multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Experience in working cross-functionally and with external providers.
• Experience with development & implementation of process improvement related initiatives.
• Strong computer and database skills.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Work in a fast-paced, demanding, and collaborative environment.
• Knowledge of grant planning or similar benchmarking tool.
• Direct negotiating with sites and vendors is a must.

Responsibilities

• Manage and may lead the day-to-day operations within Study Start Up to ensure completion of established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Negotiate and finalize site agreements, including budgets, contacts, and other necessary documentation.
• Provide accurate and up-to-date project status and financial information within relevant tracking systems/tools.
• Present the budget to the Head of Clinical Operations and Chief Accounting Officer for approval.
• Partner with Clinical and Finance teams to provide study-wide site payment estimates and forecasts.
• Work with legal counsel to ensure indemnification, liability, and confidentiality provisions in contacts.
• Provide regular updates to management on progress and KPIs related to trial agreements.
• Collaborate with Finance and Clinical Leadership to address budget, invoice, payment, and PO concerns.
• Identify and elevate issues related to support functional deliverables.
• Provide oversight and direction to team members for deliverables.
• Develop SSU Strategy and manage it during the study start up period.
• Build relationships with key study team counterparts to support site activation strategies.
• Contribute to process and tool development for SSU team day-to-day activities.
• Develop pricing strategies for site budgets to enable contract execution and activation.
• Collaborate with legal, finance, CRO and clinical teams to ensure regulatory compliance.
• Build and maintain relationships with CROs, FSP providers, and clinical sites.
• Monitor FSP providers and ensure adherence to timelines and quality standards.
• Ensure timely and cost-effective solutions meeting timelines and budgets.
• Address and resolve issues related to site agreements.
• Collaborate with Legal, Clinical Operations and Clinical Development.
• Develop innovative ideas to increase department efficiency.
• Participate in Study Team Meetings and provide metrics on site progress.

Skills

Feasibility

Study Start-Up

Contract Negotiation

Cross-Functional Collaboration

Vendor Management

Budget Development

Regulatory Knowledge (GCP/ICH)

Communication Skills

Project Management

Education

Degree in Life Sciences, Business Administration or related field

Tools

MS Office

Job description

Summit Therapeutics Inc. is seeking an experienced Manager to oversee feasibility, site start-up, and budget negotiations for our Clinical Operations teams.

The role emphasizes strong relationships with clinical sites, CROs, and internal stakeholders to accelerate site activation and ensure regulatory compliance across global trials. The ideal candidate has extensive SA start-up experience, excellent negotiation skills, and the ability to manage multi-site budgets and timelines in a fast-paced