CroíValve is looking to hire a Clinical Trial Program Manager who will support the study team in the development and execution of clinical trials globally to deliver trials per GCP, on time and within scope and budget.

This position can be fully remote within Ireland.

Key Responsibilities and Duties

• Oversee, design, plan and develop global clinical trials. Use project management skills, processes and tools to develop and execute global clinical trials on time and to budget. Work to reduce risk and maintain accurate study schedules and deliverables. Regularly communicate the study status and timelines and escalate unresolved issues appropriately to the Senior Management team

• Oversee and resolve operational aspects of clinical trials in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations. Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.

• Leverage scientific and regulatory knowledge to prepare clinical and regulatory documents (protocols, case report forms, etc).

• Develop or provide operational input to the development of study documents, including study protocols and Investigator’s Brochure

• Drive and coordinate cross-functional study team throughout site activation, enrolment, follow up and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.

• Training site personnel on study documentation.

• Support trial/regional enrolment strategy and execution.

• Oversee the timely supply of all materials to sites.

• Manage relationships and serve as a single point of contact for trial communication. Represents the company from a clinical research perspective to clinical sites.

• Oversee results of clinical investigations in preparation for new device application.

• Responsibility for management of essential documents and Trial Master File where applicable, ensuring inspection-readiness.

• Identify and assist in developing continuous improvement activities.

• Ensure interactions with colleagues/stakeholders fully reflects the company values:

o One Team: working together to ensure the whole is greater than the sum of the parts

o Personal Ownership: deliver on commitments

o Open Communication: Honest open-minded communication

o Fun: celebrate the successes

o Continuous Learning: at an individual and company level

o Solution Orientated: Identify problems but focus your energy on solutions

o Quality Focused: patient safety comes first

Education and Experience

• Degree in science or health-related field

• Minimum of four (4) years of related experience in clinical research

• Cardiovascular experience preferred

• Detailed knowledge of global/regional regulations (e.g., 21 CFR 812, ISO 14155) & Good Clinical Practice (GCP)

• Strong working knowledge of the clinical research processes and tools

• Experience of preparing clinical documentation

• Vendor management experience preferred

• Excellent communication, organisational and time management skills

• Availability to travel is required (25%)

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned from time to time.

To apply please email your CV with a cover letter to info@croivalve.com