Guided Solutions has been retained by a European Medical Technology company that is transforming the Organ Transplant market, making more organs accessible and surgery to be conducted within a time that ensures the highest quality resources. With CE Mark already established, the well-funded and already profitable company continues to build its market presence. 

To support their company growth we are looking for a Clinical Trials Director to be responsible for the oversight of global clinical trials, with full management of CROs, to ensure the smooth running of clinical trials within the business.

As Clinical Trials Director, you will plan pre-market clinical trials and post-market approval studies, oversee the selection of and being the primary point of contact for CROs and vendors, and project manages all clinical trials activities.

Our client is looking for demonstrated experience of working with CRO, including project management of the various aspects of clinical trials, and experience engaging with FDA, IRB and Health Canada for high-risk, Class III FDA medical devices. Our client seeks someone with a minimum of 3 years of experience directly managing clinical trials with a relevant scientific degree.

The candidates for this role should be located ideally in the region of East Coast, USA. This will be a remote position, with some travel.

Key responsibilities will include:

• Responsible for the efficient day-to-day management of the company’s clinical trials
• Plan and coordinate premarket clinical trials required for device registration approval as well as post-market approval studies as required
• Develop study protocols and associate documents including clinical report forms (CRF), informed consent forms (ICF), and clinical trial agreements (CTA)
• Monitor the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems; Manage monitoring and statistical support activities
• Manage the trial’s budgets and maintain the accounts as well as act as the point of contact for all external and internal agencies
• Cooperate with the Global Quality Manager as well as with other departments in the development and improvement of the clinical trials SOPs
• Establish procedures to ensure adherence to trial protocols and administrative requirements

Key skills and experience required:

• Experience with Class III FDA medical devices, and high-risk medical devices is a must for the role
• At least 3 years of demonstrated successful experience on a similar role within the clinical trials, experience with CRO is essential
• Working experience in engagement with Regulatory Agencies - FDA, IRB, and Health Canada as well as European Regulatory Agencies – MHRA
• Demonstrated experience in writing and editing annual reports for clinical trials and in the development of study protocols and associated study documents
• Educated to degree level in a relevant discipline
• Proficient with Post-market trials
• Evidence of authorship of academic publications will be considered a plus