Manager Clinical Trials Operations
Manager Clinical Trials Operations
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Job Description
Job title: Manager Clinical Trials Operations
Department: R&D
Location: Chandlers Ford Eastleigh
GLS: M03
Working hours: Monday Friday 37.5 hours per week Onsite
A brighter future awaits you
CooperVision is one of the worlds leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improvethe way people see each day. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were 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 postmarket this includes overall responsibility for clinical trial management of the clinical trial process study monitoring and oversight adherence to SOPs and regulations from a regional and postmarket 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 daytoday 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 of postmarket studies for commercial products.
- Manage clinical research associates who support the 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 crossfunctional 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 of medical device studies is essential.
- Ophthalmic experience is desirable.
- Experience managing clinical operations activities and staff.
- Excellent understanding of postmarket 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:
Youll receive competitive compensation and a fantastic benefits packageincluding 25 days holiday 10 bonus private medicalpension 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 well 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 CooperVision
What you can expect:
As a CooperVision employee youll 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 view all other opportunities.
Qualifications
#LIGA1
#LIONSITE
#INDHP
Required Experience:
Manager
Employment Type
Full-Time
