Clinical Trial Manager

Summittherapeutics; Oxford; On-site; GBP 50,000 - 80,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Clinical Trial Manager to oversee global clinical studies. The role involves managing all aspects of clinical trial operations, ensuring quality and compliance while collaborating with cross-functional teams and external partners. The ideal candidate will have extensive experience in clinical project management and a strong background in drug development.

Qualifications

• Minimum 5 years of clinical project management experience in international clinical trials.
• Experience with phase II and III trials is required.
• Strong understanding of drug development and ICH guidelines.

Responsibilities

• Oversees study scope, quality, timelines, and budget.
• Develops and manages clinical trial documents such as protocols and consent forms.
• Ensures compliance with Good Clinical Practices and regulatory requirements.

Skills

Leadership

Collaboration

Problem-solving

Communication

Time management

Education

Bachelor’s degree in life sciences, nursing, pharmacy, or related fields

Job description

Overview of Role:

The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. They oversee study start-up and maintenance through study close-out, coordinating and leading cross-functional teams, CROs, and vendors to ensure successful delivery of clinical studies. The manager is responsible for all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

1. Oversees study scope, quality, timelines, and budget with internal Summit functional leads, CROs, and vendors to meet project objectives.
2. Builds and maintains professional relationships with key opinion leaders and clinical site staff.
3. Partners with CROs to develop and execute patient enrollment strategies, ensuring timely enrollment.
4. Collaborates with CROs to develop data monitoring strategies for high-quality data delivery.
5. Proactively identifies and manages study-related risks.
6. Develops and manages clinical trial documents such as protocols, CRFs, consent forms, and confidentiality agreements.
7. Reviews and manages study-related plans and processes, including investigator agreements, analysis plans, monitoring plans, data management, and safety monitoring.
8. Reviews CRO and vendor contracts and specifications to meet study objectives.
9. Prepares essential document packages for site activation and reviews study reports at various stages.
10. Monitors findings from reports, providing updates to the team.
11. Ensures investigator adherence to protocols and addresses conduct issues and enrollment problems proactively.
12. Oversees maintenance and completeness of the Trial Master File (TMF), performing periodic QC.
13. Ensures clinical trial activities comply with Good Clinical Practices and regulatory requirements, maintaining inspection readiness.
14. Provides oversight and coaching to Clinical Trial Associates.
15. Performs other duties as assigned.

Experience, Education, and Skills:

• Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, or related fields preferred.
• Minimum 5 years of clinical project management experience in international clinical trials within Pharma/Biotech organizations.
• Experience with phase II and III trials is required.
• Strong understanding of drug development, ICH guidelines/GCP, and clinical trial processes.
• Experience with budget management and forecasting.
• Experience conducting oncology studies.
• Willingness to travel internationally up to 20%.
• Proven ability to oversee large, complex studies managed in-house and by CROs.
• Leadership skills and ability to work in a fast-paced environment.
• Excellent relationship-building skills with KOLs and site personnel.
• Strong collaboration skills with international teams.
• Ability to develop and implement patient enrollment strategies.
• Excellent interpersonal, decision-making, planning, and time management skills.
• Proficiency in reviewing and assessing clinical data.
• Strong problem-solving skills and regulatory knowledge.
• Experience working in small organizations preferred.
• Excellent written and oral communication skills.