Senior Global Clinical Project Manager

RBW Consulting; London; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An ambitious biotechnology company is seeking a Senior Global Clinical Project Manager to lead and oversee global clinical trials. This role involves managing timelines, budgets, and ensuring compliance with industry standards. You'll work collaboratively within a passionate team, driving process improvements and contributing to innovative study execution. With a focus on personal development and a supportive work environment, this position offers a unique opportunity to make a significant impact in clinical research. If you thrive in a dynamic setting and are ready to take charge of exciting projects, this is the perfect role for you.

Qualifications

• Experience in leading global clinical trials from start to finish.
• Strong understanding of ICH/GCP guidelines and SOPs.

Responsibilities

• Lead cross-functional teams for clinical study delivery.
• Manage study budgets, timelines, and vendor contracts.
• Ensure compliance with clinical trial registry requirements.

Skills

Clinical Trial Management

Budget Management

Risk Assessment

Protocol Development

Vendor Management

Patient Recruitment Strategies

Education

Bachelor's Degree in Life Sciences

Advanced Degree (Master's or PhD)

Tools

CTMS

TMF

Job description

Job Description

• Job title: Senior Global Clinical Project Manager
• Company: Biotechnology
• Location: London Area (Hybrid)

We’re looking for a Senior Clinical Project Leader who can work independently and take charge of global clinical trials from start to finish. You'll be responsible for timelines, budgets, and making sure everything runs smoothly according to company SOPs and ICH/GCP guidelines. This includes both in-house studies and those outsourced to CROs. You'll also help drive process improvements.

This is to join an ambitious Biotechnology company with a low staff turnover rate. They pay higher than the industry average in the study management space and have great opportunities for personal development. The team is very collaborative and passionate about their research.

What You'll Do:

• Lead the cross-functional team for clinical study delivery and be the main point of contact.
• Provide operational input into protocol development.
• Oversee the creation of study documents like case report forms, data management plans, monitoring plans, and more.
• Manage study systems like CTMS and TMF.
• Ensure compliance with clinical trial registry requirements.
• Identify outsourcing needs and manage vendor contracts.
• Develop and manage study budgets and timelines.
• Assess risks and create mitigation strategies.
• Select regions and countries for the study.
• Conduct site evaluations and selections.
• Prepare and execute investigator meetings.
• Monitor site activation and visits, addressing any deviations.
• Develop and implement patient recruitment and retention strategies.
• Monitor data entry and query resolution.
• Manage budgets and scope changes.
• Forecast and manage study drug and clinical supplies.
• Escalate issues related to study conduct, quality, timelines, or budget.
• Ensure CROs and vendors are aligned and delivering as expected.
• Maintain audit and inspection readiness throughout the study lifecycle.
• Support internal audits and external inspections.
• Manage study close-out activities like database lock and vendor contract reconciliation.
• Contribute to clinical study report writing and review.
• Facilitate study-level lessons learned.
• Assign tasks to Clinical Study Management staff and support their deliverables.
• Participate in process improvement initiatives.
• Identify innovative approaches to clinical study execution.
• Handle unmasked tasks for studies, including investigational product management and data review.
• Supervise CTM staff, including work assignments, performance management, recruitment, and training.

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please click ‘apply’ or contact Joe Pearce for any further information.