Clinical Site Manager

Qureight Ltd; Cambridge; Hybrid; GBP 45.000 - 65.000; Vollzeit

Benefits dieser Stelle

Private medical insurance

Life insurance

Cycle-to-work scheme

Contributory pension scheme

Equity

Zusammenfassung

Qureight Ltd. is seeking a Clinical Site Manager to oversee trial sites from qualification through active management, including data and image QC tasks.

You will coordinate onboarding, maintain site communications, and ensure regulatory compliance under GCP standards. The role requires proven site-management experience, strong organizational skills, and the ability to work with cross-functional teams across sponsors and sites.

Qualifikationen

• Demonstrated experience in clinical trial site management.
• Experience with clinical imaging (CT or MRI) desirable.
• Strong organizational and time management skills.
• Ability to cultivate key stakeholder relationships.
• Knowledge of ICH GCP with recent training.
• Experience with a QMS (ISO 9001, ISO 13485) desirable.
• Knowledge of regulatory standards (e.g., 21 CFR Part 11) desirable.
• Excellent written and verbal communication.
• Can-do attitude with drive to achieve objectives.

Aufgaben

• Conduct site qualification activities and onboarding.
• Provide site-facing communications to support activation dates.
• Manage post-qualification site activities including queries.
• Raise data queries with site staff and drive to completion.
• Act as primary contact for assigned sites.
• Respond to inbound support requests per SOPs.
• Maintain stakeholder communications in a professional manner.
• Track milestones and update internal systems.
• Support image QC processes when needed.
• Develop CT knowledge and coordinate onboarding as needed.
• Maintain site-facing documents and share as needed.
• Participate in project kick-off meetings.
• Work in line with GCP and ISO27001 data privacy.
• Drive continuous improvements and operational efficiency.
• Build relationships with sponsors, customers, and Qureight teams.
• Support general Clinical Operations activities.

Kenntnisse

Clinical site management

Organisational skills

Time management

Stakeholder relations

Communication skills

GCP knowledge

QMS ISO 9001/13485

Regulatory knowledge 21 CFR Part 11

Problem solving

Can-do attitude

Ausbildung

Life sciences degree

Jobbeschreibung

About us

Qureight’s mission is to accelerate clinical trials and ensure breakthroughs in lung and heart disease reach patients without delay. Our AI-powered data and imaging curation platform enables the analysis of clinical imaging and other healthcare data, helping our customers bring treatments to market, faster.

We’re looking for talented people who want their work to matter. With offices in Cambridge and London, you’ll join our multidisciplinary team of clinicians, scientists, and engineers. What unites us is our open culture, continuous learning mindset, and a shared mission to help biopharma run faster, smarter trials.

About the role

The Clinical Site Manager is responsible for managing clinical trial sites from site qualification to site management, including aspects of data management, image QC and query management, as part of the delivery of Qureight’s imaging CRO services. They ideally have experience in coordinating and managing clinical study sites globally or experience in a clinical trial setting generally.

A positive and can-do attitude, alongside an understanding of clinical study quality and regulatory standards is essential to the role.

You will be responsible for working with…

• Conduct Qureight site qualification activities, including site evaluation, training and scanner qualification, to ensure timely onboarding of priority clinical study sites.
• Provide proactive and effective site facing communications to support clinical trial sites in completing site qualification activities before planned activation dates.
• Be responsible for designated site management activities post site qualification including query management.
• Be responsible for raising data queries with site staff and managing them through to completion, in collaboration with data management colleagues.
• Be the point of contact for assigned clinical sites and know when to escape guidance and support.
• Respond to and resolve inbound support requests in a timely and efficient manner in line with SOPs.
• Communicate with all stakeholders in a professional and timely manner.
• Track and report project and site milestones and maintain relevant internal systems with project specific information.
• When necessary, support image check (QC) processes for assigned projects, completing timely and accurate QC in line with SOPs.
• Learn about and develop expertise in CT
• Step up to coordinate all site onboarding activities as site qualification lead for assigned projects as necessary.
• Maintain essential site facing documents, updating and sharing as needed.
• Take part in clinical project kick-off meetings where appropriate.
• Conduct work in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations.
• Be part of driving continuous improvement and operational efficiency by highlightling where improvements could be made.
• Build strong relationships with all stakeholders (at site, with sponsors, with customers and within Qureight) maintaining transparent and consistent communication throughout.
• Support general Clinical Operations activities as needed.

What we need

• Demonstrable experience in clinical trial site management
• Demonstrated experience with clinical imaging, e.g. CT or MRI is desirable but not essential.
• Strong organisational and time management skills with ability to prioritise tasks effectively.
• Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
• Knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training.
• Experience working within a Quality Management System (QMS), e.g., ISO 9001, ISO 13485 is desirable.
• Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11, is desirable.
• Strong interpersonal skills with a high proficiency in written and verbal communications.
• Track record of working effectively and problem solving in a highly technical and innovative environment, demonstrating a good attention to detail.
• Evidence of a can-do attitude with a tenacity and drive to achieve objectives.

Even better if you have…

A relevant degree, for example in life sciences,is desirable but not essential.

What can you expect from us

• A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, cycle-to-work scheme, and a contributory pension scheme
• Equity, so that our team can share in the long-term success of Qureight
• 28 days’ holiday allowance, 25 days’ annual leave and 3 additional company days between Christmas and New Year, plus bank holidays and enhanced family leave
• A diverse work environment that brings together experts in many fields, including software engineering, DevOps, data science, machine learning, quality assurance, regulatory affairs, and clinical operations.

If you have any queries, please contact [e-mail]. Everyone is welcome at Qureight. We are an equal opportunities employer and encourage applications from all suitably qualified candidates regardless of age, disability, ethnicity, sex, gender reassignment, religion or belief, sexual orientation, marriage and civil partnership, or pregnancy and maternity.

Women and other underrepresented groups may be less likely to apply for a role unless they meet all or nearly all of the requirements. If this applies to you, we still encourage you to apply – you may be a great fit, even if you don’t meet every qualification. We’d love to hear from you.

If you require any adjustments to the application or selection process, please let us know. We will be happy to support you.