At a Glance
- Tasks: Manage clinical trial sites and ensure smooth operations from qualification to completion.
- Company: Join Qureight, a pioneering company accelerating breakthroughs in lung and heart disease.
- Benefits: Enjoy a comprehensive benefits package, including bonuses, medical insurance, and generous leave.
- Other info: Diverse work environment with opportunities for growth and collaboration.
- Why this job: Make a real impact in healthcare by supporting innovative clinical trials.
- Qualifications: 2-3 years of clinical trial site management experience and strong communication skills.
The predicted salary is between 46000 - 52000 £ per year.
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.
About The Role
A Senior 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 are experienced in site facing aspects of clinical trial delivery and have significant experience in qualifying, coordinating and managing clinical study sites globally. A positive and can‑do attitude, alongside in-depth understanding of clinical study quality and regulatory standards, is essential to the role.
Responsibilities
- Lead site qualification activities for a number of concurrent clinical studies.
- Conduct Qureight site qualification activities for designated sites, including site evaluation, training, and scanner qualification, to ensure timely onboarding of priority clinical study sites.
- Support and mentor junior team members in clinical study site qualification and management.
- Provide proactive and effective site‑facing communications to support clinical trial sites in completing site qualification activities before planned activation dates.
- Manage site management activities post site qualification, including query management.
- Raise data queries with site staff and manage them through to completion.
- Serve as the point of contact for assigned clinical sites and appropriately raise escalations.
- Respond to and resolve inbound support requests in a timely and efficient manner in line with SOPs.
- Support other clinical site managers, troubleshooting issues and acting as a point of escalation when necessary.
- 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.
- Provide proactive and effective sponsor communications to ensure appropriate site status reporting is maintained for designated studies.
- Support image check (QC) processes for assigned projects, completing timely and accurate QC in line with SOPs.
- Maintain essential site‑facing documents, updating and sharing with relevant personnel as needed.
- Take responsibility for designated Trial Master File and Site File documents.
- Participate in clinical project kick‑off meetings and support bid defences as appropriate.
- Chair sponsor project meetings in the Study Manager's absence and report to sponsors as needed.
- Develop a strong working knowledge of CT, enabling independent and appropriate troubleshooting of site qualification issues.
- Lead a small team of site managers as required.
- Work in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations.
- Contribute to continuous improvement and operational efficiency by highlighting where improvements could be made and working to deliver them.
- 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 2‑3 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 pharmaceutical studies, e.g. site qualification, site training, support and site close‑out is essential.
- Demonstrated experience with clinical imaging, e.g. CT or MRI is highly desirable.
- 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.
- 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 tenacity and drive to achieve objectives.
- Relevant degree in life sciences is desirable but not essential.
Benefits
- A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, and a contributory pension scheme.
- 25 days annual leave, plus bank holidays and enhanced maternity 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.
Equal Opportunity Employer
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. If you require any adjustments to the application or selection process, please let us know. We will be happy to support you.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Site Manager
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Qureight.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Qureight.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Qureight, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Senior Clinical Site Manager
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Qureight.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Qureight.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Qureight. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Qureight. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Qureight
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Qureight’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!