Clinical Study Manager, Operations — Gene Therapy

Orchard Therapeutics plc.; Greater London; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Orchard Therapeutics plc. is a global gene therapy leader headquartered in London, England. The Clinical Operations Clinical Study Manager will oversee operational management for multiple trials, drive planning, budgeting and data integrity while ensuring patient safety and regulatory compliance.

Reporting to the Director of Clinical Operations, this role requires leadership, cross-functional collaboration and occasional international travel to meet study objectives and vendor milestones.

Qualifications

• Proven experience in pharma/biotech clinical operations and trial management.
• Experience with regulatory environments (GCP/ICH) and vendor oversight.
• Strong organizational, communication and leadership abilities.

Responsibilities

• Lead and manage clinical study activities across multiple trials.
• Collaborate with CROs, vendors and cross-functional teams to meet milestones and budgets.
• Ensure upfront planning, protocol input and feasibility assessments.
• Oversee budgeting, forecasting and financial reconciliation for studies.
• Maintain study documentation according to regulations and SOPs.
• Mentor junior team members and participate in process improvements.
• Travel approximately 20% for study meetings and site visits.

Skills

Organizational skills

Communication skills

Leadership

Collaboration

Business English

Education

BSc Life Sciences

MSc/PhD preferred

Job description

Orchard Therapeutics plc. is a global gene therapy leader headquartered in London, England. The Clinical Operations Clinical Study Manager will oversee operational management for multiple trials, drive planning, budgeting and data integrity while ensuring patient safety and regulatory compliance.

Reporting to the Director of Clinical Operations, this role requires leadership, cross-functional collaboration and occasional international travel to meet study objectives and vendor milestones.