CroíValve are looking for a Clinical Trial Manager to lead activities related to global clinical trial execution of a cutting-edge structural heart device. This role ensures all aspects of our clinical studies are conducted according to procedure and in a compliant manner. This is a remote role with monthly visits to our Dublin office.
The individual will work under minimal supervision while performing the following duties:
- Manage the clinical trials of new products for CroíValve that meet patient, customer and business needs.
- Serve as the Project Lead on one or more trials, developing plans for the trial which meet the overall company goals.
- Develop project plans, timelines, budget and resource requirements and communicate these to stakeholders.
- Strong project management skills to lead cross functional teams, including internal and external members, ensuring on time and on budget delivery. Creative approaches to reducing project risks and shortening timelines while delivering business objectives.
- Provide support to team members in the execution of the work and delivery of clinical deliverables as the product advances through the clinical trial.
- Communicate with stakeholders across the company and externally to develop project/product inputs, set and manage expectations and provide updates on project progress, risks and issues.
- Demonstrate collaborative leadership, being able to collaborate across multiple, diverse functions.
- Develop a positive team culture to ensure a high-performance engineering team, where the sum of the team output is greater than their individual parts.
- Manage external vendors/partners as necessary to support clinical activities.
- Manage 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 deliver clinical and regulatory documents (protocols, case report forms, annual reports, clinical study reports, etc).
- Plan and execute all study related activities throughout site activation (including contracting, budgeting, and regulatory submissions), enrolment, follow up (including monitoring oversight and EDC/data management) and closure. Ensuring all the clinical trial deliverables are met, including issue management, contingency planning and issue resolution.
- Lead trial/regional enrolment strategy and execution.
- Manage relationships and serve as a central point of contact for trial communication. Represent the company from a clinical research perspective to clinical sites.
- Oversee results of clinical investigations in preparation for new device application.
People Leadership
- Coach and mentor other team members, without direct supervisory authority.
- While this is predominantly a project leadership role, this role may take supervisory/management responsibility for a small number of more junior team members as required.
- Ensure interactions with colleagues/stakeholders fully reflects the company values:
- One Team: working together to ensure the whole is greater than the sum of the parts
- Personal Ownership: deliver on commitments
- Open Communication: Honest open-minded communication
- Fun: celebrate the successes
- Continuous Learning: at an individual and company level
- Solution Orientated: Identify problems but focus your energy on solutions
- Quality Focused: patient safety comes first
Essential Requirements
- Technical: Detailed understanding of clinical trials and processes for recruiting sites and patients. Ability to interpret and process clinical data.
- Problem Solving: Facilitates a culture of collaborative, data-driven problem solving within the team to ensure timely resolution of clinical issues with appropriate risk mitigation to ensure projects can progress as planned. Promotes best practice in relation to capture, analysis and communication of data to feed into clinical decision-making across the company. Risk based problem solving to ensure highest risk items in the project are addressed.
- Project Management: Extensive project management skills. Is capable of developing project plans, timelines, budget and resource requirements and communicating these to stakeholders. Translates project plans and goals into work package ownership areas for team members and aligns with management team members on individual goals and work package ownership for staff to ensure project goals are met. Uses best-in-class tools to effectively identify, track and communicate progress and project risks across all internal and external stakeholders and ensures such risks are effectively controlled with the support of other management team members. Develops creative approaches to reducing project risks and shortening timelines while delivering business objectives. Provides support to team members in the execution of the work and delivery of project deliverables as the product advances through the design development cycle. Ideally is a certified project manager, although this is not a requirement.
- Initiative: Manages the work of others and self under limited supervision and takes initiative in communication and alignment of project activities with stakeholders. Identifies knowledge / experience gaps that exist within team and takes action to address to ensure optimal performance. Is seen as a leader within the clinical organisation.
- People Skills: Has a good level of emotional intelligence and ability to build strong relationships and to positively influence collaborators / stakeholders throughout the organisation, as well as external partners. Coach and mentor more junior team members, without direct supervisory authority. Demonstrates ability to supervise/manage more junior team members.
- Communication: Communicates with stakeholders across the company and externally to develop clinical inputs, set and manage expectations and provide updates on project progress, risks and issues. Proactive communication to ensure any potential significant issues are communicated upfront. Demonstrates collaborative leadership, being able to collaborate across multiple, diverse functions. Develops a positive team culture to ensure a high-performance team, where the sum of the team output is greater than their individual parts. Manages external vendors/partners as necessary to support clinical activities.
Education and Experience
- Minimum of Bachelor’s degree in Science or Engineering, or related field
- Minimum of seven (7) years in a similar role in medical device product development, with a minimum of 3 years in project management/leadership role of clinical trials. The projects should incorporate new product development (preferably in Class III cardiovascular devices).
- Project management skills – capable of operating and liaising at all levels including managerial, project and clinical. Proven track-record in planning and resource management to meet defined project goals. Experience with processes to identify and control risks within the project. Ideally PMP or Prince 2 certified or holds similar qualification.
- Deep and current understanding of FDA, good clinical practice (GCP) and specific country regulations, with the ability to interpret these requirements and implement them into clinical trial activities.
- Experience working with clinical research organisations, including integration of their activities into the internal and site clinical activities.
- Previous experience of the planning and preparation of regulatory submission to agencies, competent authorities and/or Notified bodies.
- Excellent communication, organisational and time management skills.
- Good problem-solving mindset.
- Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Demonstrated experience in people mentoring and development without direct supervisory authority.
- At ease in start-up environment and delivers in low-structured environment with evolving priorities.
Availability to travel is required.
If you are interested in this position please send your CV with cover letter to