Senior Clinical Study Manager

Qureight; Town Of Cambridge; Hybrid; AUD 132,000 - 208,000; Full time

Benefits offered by this job

Annual bonus plan

Private medical insurance

Life insurance

Cycle-to-work scheme

Contributory pension

Job summary

Qureight is seeking a Senior Clinical Study Manager to lead start-up and ongoing study management for allocated studies. You will be the main point of contact for customers and internal teams, manage risks, and report financial milestones to support invoicing and reconciliation.

This hybrid role is based out of Cambridge or London and requires strong GCP knowledge, QMS experience, and effective stakeholder management to deliver trials to high standards.

Qualifications

• Minimum of 4 years in clinical research, ideally in imaging CRO or trial delivery.
• Experience as a project or study manager in clinical research.
• Knowledge of GCP and regulatory standards.
• Experience with QMS (ISO 9001/13485) or similar.
• Strong stakeholder management and communication skills.

Responsibilities

• Take overall responsibility for the operational delivery of assigned studies from initiation to close out.
• Serve as the primary contact for customers and internal teams.
• Lead client meetings, write agendas and status updates.
• Develop and maintain study plans, timelines and documentation.
• Monitor risks, issues and dependencies; implement mitigation.
• Oversee study financial milestones and support invoicing and forecasting.
• Ensure adherence to Qureight SOPs, GCP, ISO standards and data privacy rules.
• Mentor more junior team members and drive process improvements.

Skills

Stakeholder management

GCP knowledge

QMS experience

Regulatory knowledge

Project management

Communication skills

Imaging clinical research

Education

Degree in biomedical science or related field

Job description

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

We are seeking an experienced Senior Clinical Study Manager to join our Clinical Operations team at Qureight. In this role you will lead study start up and ongoing study management activities for your allocated studies/projects, ensuring they are delivered on time and to a high standard.

As a study management lead, you will serve as the primary point of contact for both customers and internal teams. You will write key study documents, lead customer meetings, and proactively manage risks and issues. Working closely with operational colleagues you will report project financial details and achievement of milestones to support invoicing and reconciliation.

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 the Cambridge or London office.

What you will do

• Take overall responsibility for the operational delivery of assigned customer projects/clinical studies from initiation through to close out, ensuring delivery against agreed scope and timelines.
• Be the Qureight subject matter expert for assigned studies, maintaining oversight of study-specific requirements, deliverables and operational performance.
• Develop and maintain study plans, timelines, trackers and other study management documentation.
• Support and work alongside clinical site managers and clinical data managers in the delivery of study milestones.
• Collaborate effectively with internal and external stakeholders, building a strong working relationship with them.
• Act as a senior point of contact and trusted partner for assigned clients.
• Establish and maintain strong, long-term client relationships.
• Lead client meetings, prepare agendas and status updates, and ensure actions are documented and followed through.
• Maintain comprehensive oversight of study risks, issues and dependencies.
• Anticipate operational challenges and proactively develop mitigation and contingency strategies.
• Deliver study start-up activities, including leading Kick-off Meetings and creating, reviewing and releasing Key Study Documents and other required study documents.
• Own and manage project level change, assessing the impact on scope, timeline, resources and financial performance, working closely with Business Development and other functions as required.
• Maintain oversight of study financial milestones and contribute to financial forecasting, invoicing, reconciliation and deliverable tracking.
• Deliver all study management activities to a high standard and in accordance with Qureight SOPs, Good Clinical Practice (GCP) guidelines, ISO27001 standards, data privacy regulations and all other applicable regulations.
• Play a driving role in developing and maintaining Qureight study management processes, looking for and delivering process improvement opportunities throughout the study lifecycle. This includes writing and reviewing SOPs.
• Support and have oversight of more junior team members, providing mentorship and guidance.

What we need

• Minimum of 4 years of clinical research experience ideally in an imaging Clinical Research Organisation or other clinical trial delivery environment.
• Experience as a project manager or study manager in clinical research is essential, with a particular focus in lung and heart pharmaceutical trials being desirable.
• Previous experience working with clinical trial imaging is highly desirable but not essential.
• Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
• Excellent 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.
• Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11.
• 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.
• Experience of, or formal qualification in, project management.

Even better if

• A degree in a relevant scientific or technical area, e.g. biomedical science, is beneficial, 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.