Clinical Study Lead - Imaging Trials

Qureight Ltd; Cambridge; Hybrid; GBP 50,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Private medical insurance

Life insurance

Cycle-to-work scheme

Contributory pension

Job summary

Qureight Ltd, based in the UK with offices in Cambridge and London, seeks an experienced Clinical Study Manager to join the Clinical Operations team. You will lead start-up and ongoing management of allocated studies, ensuring deliverables meet high standards and regulatory expectations.

You will develop study plans, track milestones, report financial details for invoicing, and work with internal and external stakeholders to drive successful delivery.

Qualifications

• 2+ years of clinical research experience, ideally in imaging CR environment.
• Experience as a project manager or start-up specialist in clinical research is desirable, with focus on lung and heart trials.
• Exposure to clinical trial imaging is highly desirable but not essential.
• Proven ability to cultivate and maintain key stakeholder relationships.
• Knowledge of ICH GCP with recent training.
• Experience within a QMS (ISO 9001, ISO 13485).
• Familiarity with regulatory standards e.g. 21 CFR Part 11.
• Strong interpersonal and written/verbal communication skills.
• Track record of solving problems in technical, innovative settings.
• Evidence of a can-do attitude and drive to achieve objectives.
• Experience or qualification in project management.

Responsibilities

• Lead delivery of assigned customer projects/clinical studies from kick-off through maintenance and close-out.
• Develop and maintain study plans, timelines, trackers and other study docs.
• Monitor progress against milestones; identify risks and dependencies early.
• Coordinate and lead study meetings with agendas and status updates.
• Engage with customers to define project goals and requirements.
• Collaborate with internal and external stakeholders at planned frequencies.
• Support clinical site managers and data managers to meet milestones.
• Deliver start-up activities including Kick-off Meetings and key study documents.
• Own change and risk management at the project level.
• Track financial milestones and coordinate with Finance for invoicing.
• Ensure all activities align with SOPs, GCP, ISO27001, data privacy, and regulations.
• Support Clinical Operations process improvements.

Skills

Clinical Study Management

Project Management

Communication skills

Attention to detail

Education

Degree in a relevant scientific field

Job description

Qureight Ltd, based in the UK with offices in Cambridge and London, seeks an experienced Clinical Study Manager to join the Clinical Operations team. You will lead start-up and ongoing management of allocated studies, ensuring deliverables meet high standards and regulatory expectations.

You will develop study plans, track milestones, report financial details for invoicing, and work with internal and external stakeholders to drive successful delivery.