EU Clinical Operations Manager

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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