Clinical Operations Manager
2 days ago
🔄 Hybrid – Cambridge
Description
• The Clinical Operations Manager is responsible for the delivery of Qureight’s clinical study services to pharmaceutical, CRO and academic customers. • 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. • 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.
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, 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. • Experience of, or formal qualification in, project management. • Experience in clinical and medical affairs for software medical devices.
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 in a vibrant and fast-acting company. • Experience in a highly regulated industry where high-quality code is essential. • Co-working passes.
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