Clinical Trial Manager

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 138,000 - 160,000; Full time

Job summary

A biopharmaceutical oncology company is seeking a Clinical Trial Manager to oversee global studies from startup to closeout. The role involves coordinating cross-functional teams and ensuring compliance with guidelines. Candidates should have a Bachelor's degree, 5+ years of experience in clinical project management, and strong leadership skills. The compensation ranges from $138,000 to $160,000 annually, with additional benefits such as bonuses and stock options.

Qualifications

• 5+ years of clinical project management experience in international Phase II/III trials.
• Strong understanding of drug development and ICH guidelines.
• Experience with budget forecasting and management.

Responsibilities

• Define and manage study scope, quality, timelines, and budget.
• Build relationships with key opinion leaders and site staff.
• Collaborate with CROs on patient enrollment and data monitoring.

Skills

Clinical project management

Leadership skills

Communication skills

Problem-solving abilities

Time-management

Budget forecasting

Oncology study experience

Education

Bachelor's degree in life sciences or related field

Job description

Company Overview

Summit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving quality of life, extending life expectancy, and addressing serious unmet medical needs. Basing its mission on integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people, the company fosters a culture centered around world‑class professionals who drive its objectives forward.

Role Overview

As a Clinical Trial Manager, you will leverage extensive experience in clinical operations to oversee all phases of global studies from startup to closeout. You will coordinate and lead cross‑functional teams, CROs, and vendors to ensure high‑quality deliverables and maintain a strong focus on performance metrics and regulatory compliance.

Position Details

Base Pay Range: $138,000 – $160,000 per year
Additional compensation: Annual bonus and stock options.

Responsibilities

• Define and manage study scope, quality, timelines, and budget with Summit leads, CROs, and vendors.
• Build professional relationships with key opinion leaders and site staff.
• Collaborate with CROs to develop and execute robust patient enrollment and data monitoring strategies ensuring on‑time completion.
• Identify and mitigate study‑related risks proactively.
• Develop and manage clinical trial documents such as protocols, CRFs, consent forms, and confidentiality agreements.
• Review study plans and processes, including CTA, CRF guidelines, statistical / PK analysis plans, monitoring plan, data management, and safety monitoring.
• Oversee CRO and vendor contracts/work orders to meet study objectives.
• Approve essential document packages for timely site activations and oversee monitoring reports.
• Ensure investigator adherence to protocol, addressing conduct and enrollment issues as needed.
• Maintain the TMF and perform periodic QC to ensure completeness.
• Ensure compliance with GCP, ICH guidelines, and company SOPs, keeping the study “inspection‑ready” at all times.
• Coach and supervise Clinical Trial Associates within the project.
• Perform any other duties as assigned.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, medical laboratory technology, or related field (preferred).
• 5+ years of clinical project management experience in international Phase II/III trials at a sponsor Pharma/biotech organization.
• Strong understanding of drug development, ICH guidelines, GCP, and the complete clinical trial process.
• Experience with budget forecasting and management.
• Oncology study experience.
• International travel for site visits and study meetings (up to 20%).
• Proven proficiency managing large, complex studies in house or via CRO.
• Excellent interpersonal, leadership, and decision‑making skills with the ability to innovate and drive program objectives.
• Strong communication (written and oral) and coordination abilities.
• Experience working in a small organization.
• Ability to build and execute patient enrollment strategies and maintain rigorous data quality standards.
• Excellent time‑management and problem‑solving skills with a clear judgment on regulatory requirements and timelines.

Summit does not accept referrals from employment businesses or agencies for this vacancy. Only direct applicants or authorized referrals will be considered. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team for written authorization before referring any candidates.