Clinical Project Manager

R&D Partners; City Of London; On-site; GBP 70,000 - 110,000; Full time

Job summary

R&D Partners seeks a Clinical Project Manager to oversee gene therapy trials, coordinating timelines, budgets, and regulatory submissions.

You will liaise with CROs, sites, and vendors to ensure on-time delivery and compliance, while mentoring Clinical Trial Managers. Knowledge of ICH-GCP, GDPR, and Veeva Vault is preferred, with experience across US/UK/EU frameworks.

Qualifications

• Experience managing clinical trials, especially gene therapy programs.
• Strong knowledge of ICH-GCP and GDPR.
• Ability to coordinate CROs, vendors, and clinical sites.
• Excellent organizational and communication skills.

Responsibilities

• Manage day-to-day operations of clinical trials from start to finish.
• Ensure trials meet timelines, budgets, and quality standards.
• Oversee trial start-up activities: site selection, contracts, budgets, regulatory submissions.
• Manage relationships with service providers, vendors, and sites.
• Monitor study budgets and regulatory compliance.
• Lead team meetings, track progress, and resolve action items.
• Maintain accurate reporting of trial data and documentation for inspections.
• Identify risks and implement mitigation strategies.
• Support development of study documents such as protocols and consent forms.
• Collaborate with investigators and external consultants.
• Contribute to quality management systems and audits.

Skills

Clinical trial processes

ICH-GCP & GDPR

Stakeholder management

eTMF systems (Veeva Vault)

Phase 1 trials knowledge

Leadership & mentoring

Regulatory submissions

Tools

Veeva Vault

Job description

Looking to be the heartbeat of clinical research? Join our client in this project management position and assist in turning innovative science into life-changing care!

R&D Partners is seeking Clinical Project Manager to oversee the day-to-day operations of gene therapy clinical trials. You will play a pivotal role in managing study timelines, budgets, and compliance, ensuring trials are delivered efficiently and to the highest standards. The position requires close collaboration with internal departments, vendors, and stakeholders to achieve successful study outcomes.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Manage day-to-day operations of clinical trials from start to finish.
• Ensure trials are completed on schedule, within budget, and meet quality standards.
• Oversee trial start-up activities, including site selection, contracts, budgets, and regulatory submissions.
• Manage relationships with service providers, vendors, and clinical sites.
• Monitor study budgets and ensure financial compliance.
• Lead team meetings, track progress, and resolve action items.
• Maintain accurate and timely reporting of trial data.
• Ensure proper setup and maintenance of trial documentation for inspection readiness.
• Identify risks, implement mitigation strategies, and address challenges proactively.
• Support the development of study documents such as protocols and consent forms.
• Collaborate with investigators, key opinion leaders, and external consultants.
• Contribute to the development and improvement of clinical quality management systems.
• Participate in audits and inspections as needed.

Key Skills and Requirements:

• Strong understanding of clinical trial processes and regulations, particularly in the USA, UK, and EU.
• Knowledge of ICH-GCP guidelines and general data privacy regulations (e.g., GDPR).
• Proficiency in tools like Word, Excel, PowerPoint, and eTMF systems (Veeva Vault experience preferred).
• Ability to manage multiple stakeholders, including CROs, clinical sites, and vendors.
• Experience in managing clinical trials across all phases, especially Phase 1 (First-in-Human) trials.
• Background in biological sciences or a related field is preferred.
• Strong organizational, communication, and problem-solving skills.
• Provide leadership and mentorship to Clinical Trial Managers and/or Clinical Trial Administrators.

For more information, please contact Giovanni Esposito.