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Clinical Operations Manager

2 months ago

Cambridge, Cambridgeshire, United Kingdom Qureight Ltd Full time
About Qureight Ltd

Qureight Ltd is a MedTech company based in the UK, founded in 2018 by doctors with a mission to improve patient lives using big data and machine learning.

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

Job Summary

The Clinical Operations Manager is responsible for delivering Qureight's clinical study services to pharmaceutical, CRO, and academic customers, working closely with teams across the business. This is a hybrid role based out of our Cambridge office.

Key Responsibilities
  • Collaborate with partners and customers to understand study goals and objectives, establishing client requirements.
  • Manage multiple stakeholders to ensure alignment of clinical study service requirements and communication of all change requests.
  • Lead the development of standard procedures, protocols, charters, data transfer agreements, case report forms, and other documents, ensuring necessary quality standards are maintained.
  • Work collaboratively across the organization to ensure client requirements are implemented correctly and in line with Qureight's standard operating procedures.
  • 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, working with programme management colleagues to ensure delivery is on time and in budget.
  • Ensure all customer activities are completed in compliance with ICH GCP and relevant regulatory requirements.
  • Manage site, partner, vendor, and contractor relationships, including onboarding, training, and competency requirements.
  • Provide regular reporting of project status to internal and external stakeholders, identify and resolve issues, and escalate unresolved issues.
Requirements
  • 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.
  • Expert knowledge of ICH Good Clinical Practice (GCP) with recent training.
  • Experience working within a Quality Management System (QMS).
  • Knowledge of relevant regulatory, compliance, and industry standards.
  • Strong interpersonal skills with high proficiency in written and verbal communications.
  • Track record of working effectively and problem-solving in a highly technical and innovative environment.
  • Evidence of a can-do attitude with 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
  • Bachelor's degree (or higher) in a relevant biomedical or healthcare-related field.
  • Good Clinical Practice (GCP) training.
Benefits
  • 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.