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:

As EU Clinical Operations Manager, you will be responsible for leading the clinical operations team and for ensuring all clinical trial activities are carried out in accordance with the company's program goals and timeline, budget and quality expectations.

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:

As EU Clinical Operations Manager you will require:

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

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