Clinical Site Manager

TN United Kingdom; Cambridge; On-site; GBP 35,000 - 60,000; Full time

Job summary

Join a forward-thinking BioTech company dedicated to improving patient outcomes through innovative imaging solutions. As a Clinical Site Manager, you'll be at the forefront of clinical trial imaging studies, managing site qualifications, ensuring compliance with regulatory standards, and fostering strong relationships with stakeholders. This hybrid role offers the flexibility of working from home while requiring in-person attendance at the Cambridge office up to two days a week. With a commitment to continuous improvement and operational efficiency, you'll play a crucial role in driving the success of clinical research projects. If you thrive in a dynamic environment and are passionate about making a difference in healthcare, this opportunity is perfect for you.

Benefits

25 days annual leave plus bank holidays

Salary exchange pension scheme

Private medical insurance

Discretionary employee share options

Opportunities for professional development

Qualifications

• Minimum of 2 years in clinical trial site management, ideally in imaging.
• Strong project management skills and ability to prioritize tasks.

Responsibilities

• Manage clinical sites from qualification to ongoing support.
• Conduct image quality checks and ensure compliance with GCP.

Skills

Clinical trial site management

Project management

Stakeholder relationship management

Good Clinical Practice (GCP)

Problem-solving

Attention to detail

Education

Relevant degree in life sciences or related field

Tools

Quality Management System (QMS)

Job description

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About Qureight:

Qureight is a BioTech company based in Cambridge, UK. We were founded in 2018 by doctors with the mission of using big data and machine learning to improve the lives of patients with complex, life-changing diseases.

At our heart we are a core imaging lab and imaging CRO. Our advanced machine learning models analyse CT scans to classify and quantify diseases and predict disease progression. These digital biomarkers of disease are used by our pharmaceutical customers to obtain new insights into their clinical drug trials and quantify and track treatment response.

Position Summary:

The Clinical Site Manager is responsible for managing clinical sites from site qualification to site management, including image QC and query management, as part of the delivery of Qureight’s imaging CRO services. They are experienced in delivering for clinical trial imaging studies, and have experience in qualifying, coordinating and managing clinical study sites. A positive and can-do attitude, alongside in-depth understanding of clinical study quality and regulatory standards is essential to the role.

This is a hybrid role based out of our Cambridge office, with in person attendance required, up to 2 days a week.

Responsibilities:

• Conduct site qualification activities, including site evaluation, training and scanner qualification, to ensure timely onboarding of priority clinical study sites.
• Be the point of contact for assigned clinical sites and know when to escalate internally for guidance and support.
• Respond to and resolve queries in a timely and efficient manner in line with SOPs.
• Communicate with stakeholders in a professional and timely manner.
• Conduct and be responsible for image check (QC) processes for assigned projects, completing timely and accurate QC in line with SOPs.
• Take part in clinical project kick-off meetings where appropriate, and support bid defences.
• Conduct work in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations.
• Track and report project and site milestones and maintain relevant internal systems with project specific information.
• Be part of driving continuous improvement and operational efficiency by highlighting where improvements could be made, suggesting revisions for work instructions and bringing experienced insights.
• Step up to coordinate all site onboarding activities for assigned projects as necessary.
• Maintain essential site documents, updating and sharing as needed.
• 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.

Requirements:

• Minimum of 2 years of clinical trial site management experience, ideally in an imaging Clinical Research Organisation or Core Imaging Lab.
• Experience of clinical study site qualification and management for imaging studies, e.g. site qualification, site training, support and site close out.
• Demonstrated experience with clinical imaging.
• Strong project management skills with ability to prioritise tasks effectively.
• Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
• Expert 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.

Qualifications & Education:

The chance to join a friendly, motivated group of people on a mission for universal good in healthcare.

• 25 days annual leave, plus bank holidays.
• Salary exchange pension scheme.
• Private medical insurance (including pre-existing).
• Discretionary employee share options scheme.
• Opportunities for professional development and academic collaborations in a vibrant and fast-acting company.

Qureight reserve the right to amend or remove any of these at any given time.

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Advert last updated on 04/04/2025 by TN United Kingdom.