CK Group are working in partnership with a clinical stage medical device company developing a neuromodulation device. This will be a hybrid role requiring attendance at their offices near Abingdon once a week, as well as up to two days a week, visiting sites around Europe.
RESPONSIBILITIES:
* Management of the clinical operations team and ensuring successful study outcomes
* Oversight of academic clinical collaboration trials
* Development and maintenance of departmental procedures
* Responsibility for the selection and management of CROs
* Development of relationships with Principal Investigators and Key Opinion Leaders
* Oversight of the compilation of clinical trial submissions, clinical study reports and clinical evaluation reports
QUALIFICATIONS:
* A relevant BSc
* Proven experience of clinical operations management in a medical device company or CRO
* Experience of the set-up, management and close-out of EU CR mark trials
* Experience of managing a clinical operations team
* Experience of the selection and management of CROs
* Expert knowledge of GCP, FDA regulations, EU MDR and ISO14155
* Excellent leadership and project management skills
BENEFITS:
Salary of £65,000-£75,000 plus benefits package.
Apply: Please quote job reference 108 117 in all correspondence.
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