Clinical Project Manager

Description:

Clinical Project Manager Full time - Galway (Hybrid) We have an exciting opportunity for a Clinical Project Manager to join Veryan Medical! Summary Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in SFA interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine. Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges. Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say. Reporting to the VP Scientific Affairs, the Clinical Project Manager will be responsible for ensuring that all clinical evaluations sponsored or conducted by Veryan are designed and executed in accordance with timelines, budgets, relevant legislation and regulations, GCP/ICH guidelines and Veryan SOPs. This is a fantastic opportunity which will allow the successful candidate to work as part of a highly experienced, supportive, and collaborative team, who produce high-quality work in a fast-paced environment. Job Requirements Principal Responsibilities

• Develop clinical study design concepts in line with the requirements of the business plan and work with internal and external resources to refine these plans into comprehensive clinical projects with associated implementation plans and budgets.

• Provide leadership of agreed clinical studies working with internal and external resources to secure timely and successful conclusion within the allocated budget and resources.

• Develop clinical study protocols and study related documentation and ensure the development, production and filing of required documents is managed within the Quality System requirements.

• Proactively identify sites for clinical investigation and conduct feasibility, qualification, initiation and visits as required to assess and monitor compliance.

• Ensure that investigators and investigational site staff are provided with clinical support as required to achieve the highest standard of proficiency in use of the Company’s products and compliance with the study protocol(s).

• Escalate medical issues to the VP Scientific Affairs and/ or Veryan’s CMO.
• Establish Data Monitoring Committees, prepare and conduct regular meetings.
• Ensure that internal and external resources applied to each clinical project are managed efficiently and with effective oral and written communication throughout the project team.

• Contribute to the ongoing scientific review of Veryan’s clinical database and draft or contribute to the preparation of manuscripts for regulatory and publication purposes.

• Provide Clinical Affairs Input to regulatory submission documents (e.g. Clinical Evaluation Report, Periodic Safety Update Report, Post-Market Clinical Follow-up) and the risk management file.

• Set-up and maintain external Corelabs. Education & Training

• A Bachelor’s degree in a scientific or health-related field is required. • Strong knowledge of the clinical research process, including working