Job Description
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 £65-75K plus benefits package