Clinical Study Manager (Medical Devices)

Description:

Talentmark are looking for a Clinical Study Manager (Medical Devices) to join a well financially backed medical device company who’s product is progressing well in human studies. This is a hybrid role, you would need to be on-site in Oxfordshire once a week. 

The Role:

As Clinical Study Manager, you will take ownership of the operational delivery of international clinical studies, ensuring they are executed on time, within budget and in compliance with study protocols, Good Clinical Practice, ISO 14155 and internal quality standards.

This is an exciting opportunity to play a key role in bringing innovative medical technologies to patients, with regular travel across Europe to support clinical trial sites and our Belgium office, and occasional travel to the US to support clinical sites and patient visits.

Responsibilities:

Lead study start-up activities, including site selection, qualification and activation.
Manage CROs, vendors and third-party suppliers to ensure high-quality, timely delivery.
Monitor site performance, patient recruitment and operational progress, implementing solutions to overcome challenges.
Ensure compliance with study protocols, Good Clinical Practice (GCP), ISO 14155, regulatory requirements and company SOPs.
Collaborate cross-functionally to support product improvements, technical investigations and issue resolution.
Build and maintain strong relationships with investigators, key opinion leaders and clinical sites.
Provide operational support for clinical sites, including site and patient visits where required.
Support audit readiness, inspections, data integrity and timely resolution of data queries.
Travel regularly throughout Europe, with occasional travel to the US, to support clinical trial activities. 

Your Background:

Bachelor’s degree in a scientific or health-related field or equivalent.
Extensive experience in clinical trial management in medical devices.
Experience of set-up, management and closeout of EU CE mark trials.
Strong knowledge of GCP and ISO14155.
Proven experience in vendor oversight and cross-functional leadership.
Excellent written and oral communication skills.
Effective team-player, agile and thrives in versatile environment. 

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence