Senior Clinical Study Manager: Rare Diseases, Phase 3 Lead

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 85,000 - 115,000; Full time

Benefits offered by this job

Company pension scheme

Private Health Insurance

Life and Critical Illness Insurance

Corporate Gym membership

Regular team building events

Agile working environment

Job summary

Cycle Pharmaceuticals Ltd in Cambridge is seeking a Senior Clinical Study Manager to oversee the operational delivery ofPhase 3 trials and Phase 4 post-approval studies across rare diseases. The role is hybrid, with a minimum of three days in the Cambridge office, reporting to the Associate Director of Clinical Operations.

You will own studies from feasibility to final clinical study report, manage timelines, budgets and quality, and collaborate across cross-functional teams to ensure regulatory

Qualifications

• Degree in life sciences or related discipline, advanced degree preferred.
• Extensive clinical operations experience in pharma/biotech/CRO.
• Experience leading Phase 3 studies and post-approval initiatives.

Responsibilities

• Delivery of Phase 3 studies feasibility through database lock and final report.
• Lead country/site selection and recruitment strategies, including pediatric populations.
• Coordinate supply planning, randomisation, analyses, and monitoring activities.
• Oversee post-approval studies and regulatory commitments with CROs/vendors.
• Ensure GCP/regulatory compliance and maintain eTMF; support audits.
• Develop budgets, monitor KPIs and study spend; escalate risks promptly.
• Mentor team members and potentially take on line management in future.

Skills

Clinical operations

Project management

FDA/US regulatory knowledge

Stakeholder management

Decentralised/trial approaches

Cross-functional collaboration

Risk & issue management

Travel readiness

Education

Life sciences degree

Advanced degree preferred

Tools

eTMF

Job description

Cycle Pharmaceuticals Ltd in Cambridge is seeking a Senior Clinical Study Manager to oversee the operational delivery ofPhase 3 trials and Phase 4 post-approval studies across rare diseases. The role is hybrid, with a minimum of three days in the Cambridge office, reporting to the Associate Director of Clinical Operations.

You will own studies from feasibility to final clinical study report, manage timelines, budgets and quality, and collaborate across cross-functional teams to ensure regulatory