Job Description

Job Category: Clinical Life Science:Job title: Manager, Clinical Trials OperationsDepartment: R&DLocation: Chandlers Ford, EastleighGLS: M03Working hours: Monday - Friday 37.5 hours per week - OnsiteA brighter future awaits youCooperVision is one of the world's leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It's more than making contact lenses, it's about giving lens wearers freedom and confidence to move about their daily lives. We're all about bright futures - for our people and those who wear our contact lenses.Job summary - What to expect:As the Manager of Clinical Trials Operations within our R&D team, you will provide operational leadership for global clinical activities conducted during product research & development and post-market surveillance. Specifically, this includes overall responsibility for clinical trial execution, management of the clinical trial process, study monitoring and oversight, adherence to SOPs and regulations from a regional and post-market surveillance perspective; and Good Clinical Practice (GCP) compliance.Specifically, you will:

• Oversee Clinical Operations and procedures to ensure compliance with regional and global medical device GCP requirements while maintaining and improving operational efficiency.
• Manage the day-to-day activities of the clinical team including study and site management, availability of clinical supplies, lens accountability (i.e. shipping, receiving and traceability of investigational products) as well as all requirements related to the execution of post-market studies for commercial products.
• Manage clinical research associates who support the execution of all clinical operations activities.
• Lead clinical site administrative activities including investigator agreements, contracts, and budgets, and oversees site qualification, site initiation, monitoring, and closeout activities, as well as data management activities.
• Manage regulatory submissions and ensures all necessary approvals are obtained prior to study initiation and ensures appropriate safety reporting per local/regional requirements.
• Manage ongoing communication of clinical operations issues and provides progress reports on assigned activities to the Director of Clinical Operations and Global Clinical Team.
• Foster a strong working relationship with R&D, Regulatory Affairs and Quality Assurance groups, working together to ensure compliance in all clinical activities.
• Partner with Clinical Project/Program leads in protocol and informed consent form (ICF) development, Case Report Form (CRF) design, project plans, and clinical report writing.
• Represent Clinical Operations/R&D in internal and external audits.

A full job description is available upon request.About you:We are looking for someone who has the following experience

• Proven experience of Operations Management in clinical research or similar experience in a medical/scientific area, plus experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting is essential.
• Happy to be hand on in their approach with people management experience as you will be managing 2 direct reports.
• CRA experience, or equivalent, involving the management and execution of medical device studies is essential.
• Ophthalmic experience is desirable.
• Experience managing clinical operations activities and staff.
• Excellent understanding of post-market clinical trial procedures, especially regional (UK & EU) regulations and best practices.
• Strong understanding of GCP and clinical study and site monitoring practices with a track record for ensuring quality data and performing effective site management.
• Understanding of data management regulations in clinical trials, including having experience with electronic data management systems.
• Must have a high degree of accuracy and attention to detail, excellent writing, verbal communication, interpersonal and diplomacy skills.
• Medical and technical aptitude; knowledge in ophthalmic medical devices is desirable.

What we offer:You'll receive competitive compensation and a fantastic benefits package including 25 days holiday, 10% bonus, private medical, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!We are committed to our employees' personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we'll give you everything you need to help you achieve yours.We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVisionWhat you can expect:As a CooperVision employee, you'll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success.If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.Please view our careers page at to view all other opportunities.Qualifications:#LI-GA1#LI-ONSITE#INDHPAbout Us:CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employee-centric culture fuel a deeply engaged, high performing organization.CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That's a strong reflection of our corporate culture-and part of the reason CooperVision may be a great workplace for you.

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