Clinical Operations Manager

About Qureight:

Qureight is a MedTech 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 diseases.

At Qureight, we develop machine learning models to analyse clinical imaging data, extract biomarkers and improve diagnosis and prognosis of complex heart and lung diseases. We partner with biopharma companies and academic institutions who use the Qureight Platform to obtain new insights into diseases and assess treatment response during clinical trials.

Position Summary:

The Clinical Operations Manager is responsible for the delivery of Qureight’s clinical study services to pharmaceutical, CRO and academic customers, working in close collaboration with teams across the business. They are a subject matter expert, providing leadership in clinical trial operational matters, and regulatory and compliance needs. This is a hybrid role based out of the Cambridge office.

Requirements

Roles and Responsibilities:

• Work with partners and customers to understand study goals and objectives, helping to establish the clients’ requirements.
• Manage multiple stakeholders to ensure alignment of clinical study service requirements and communication and agreement of all change requests.
• Lead development of standard procedures, protocols, charters, data transfer agreements, case report forms and other documents as required, ensuring necessary quality standards are maintained.
• Work collaboratively across the organisation to ensure client requirements are implemented correctly and in line with Qureight’s standard operating procedures. This includes liaison with technical product teams to manage product software and configuration change requests.
• Establish improvements in Qureight’s procedures and ways of working to continually learn from and improve the quality of the services we offer.
• Provide operational oversight of all customer study activities, and work with programme management colleagues to ensure delivery is on time and in budget.
• Ensure that all customer activities are completed in compliance with ICH GCP and relevant regulatory requirements.
• Manage all site, partner, vendor and contractor relationships including any onboarding, training and competency requirements, producing necessary materials as required.
• Provide regular reporting of project status to internal and external stakeholders, identify and resolve issues, and escalate all issues that remain unresolved.

Essential Experience and Skills:

• Minimum of 3 - 5 years of trial management experience in the pharmaceutical or medical device industry.
• Experience working with Clinical Research Organisations (CROs), or equivalent.
• Familiarity with the design and implementation of standard trial processes, e.g., subject selection and enrolment, event adjudication, monitoring, database locking, study read out and archiving.
• 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.
• 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.

Desirable:

• Experience of, or formal qualification in, project management.
• Experience in clinical and medical affairs for software medical devices.

Qualifications / Education:

• A bachelor’s degree (or higher) in a relevant biomedical or healthcare-related field.
• Good Clinical Practice (GCP) training.

Benefits

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

• Flexible working hours.
• Hybrid working policy.
• Competitive salary.
• 25 days annual leave, plus bank holidays.
• Contributory pension.
• Private medical insurance (including pre-existing).
• Medical Cash Plan benefit.
• Discretionary employee share options scheme.
• Opportunities for professional development and academic collaborations in a vibrant and fast-acting company.
• Experience in a highly regulated industry where high-quality code is essential.
• Co-working passes.