Clinical Site Manager

Qureight Ltd; Cambridge; Hybrid; GBP 35,000 - 55,000; Full time

Job description

No agencies please, any enquiries, please email [e-mail]

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:

1. Conduct site qualification activities, including site evaluation, training and scanner qualification, to ensure timely onboarding of priority clinical study sites.
2. Be responsible for site management activities post site qualification including query management.
3. Be the point of contact for assigned clinical sites and know when to escalate internally for guidance and support.
4. Respond to and resolve queries in a timely and efficient manner in line with SOPs.
5. Communicate with stakeholders in a professional and timely manner.
6. Conduct and be responsible for image check (QC) processes for assigned projects, completing timely and accurate QC in line with SOPs.
7. Take part in clinical project kick-off meetings where appropriate, and support bid defences.
8. Conduct work in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations.
9. Track and report project and site milestones and maintain relevant internal systems with project specific information.
10. 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.
11. Step up to coordinate all site onboarding activities for assigned projects as necessary.
12. Maintain essential site documents, updating and sharing as needed.
13. Build strong relationships with all stakeholders (at site, with sponsors, with customers and within Qureight) maintaining transparent and consistent communication throughout.
14. Support general Clinical Operations activities as needed.

Requirements:

1. Minimum of 2 years of clinical trial site management experience, ideally in an imaging Clinical Research Organisation or Core Imaging Lab.
2. Experience of clinical study site qualification and management for imaging studies, e.g. site qualification, site training, support and site close out.
3. Demonstrated experience with clinical imaging.
4. Strong project management skills with ability to prioritise tasks effectively.
5. Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
6. Expert knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training.
7. Experience working within a Quality Management System (QMS), e.g., ISO 9001, ISO 13485 is desirable.
8. Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11, is desirable.
9. Strong interpersonal skills with a high proficiency in written and verbal communications.
10. Track record of working effectively and problem solving in a highly technical and innovative environment, demonstrating a good attention to detail.
11. Evidence of a can-do attitude with a tenacity and drive to achieve objectives.

Qualifications & Education:

1. Bachelors degree (or equivalent) in life sciences.

Benefits:

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

1. Flexible working hours.
2. Hybrid working policy.
3. Competitive salary.
4. 25 days annual leave, plus bank holidays.
5. Salary exchange pension scheme.
6. Private medical insurance (including pre-existing).
7. Medical Cash Plan benefit.
8. Death In Service benefit.
9. Discretionary employee share options scheme.
10. Opportunities for professional development and academic collaborations in a vibrant and fast-acting company.
11. Co-working passes.

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