At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We've been recognised as a Great Place to Work And we're proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women.
At Eakin Healthcare, we're united by one mission: working together to improve lives - just like we've been doing for over five decades.
WHY JOIN US?
We're good at what we do – come and join us and you can benefit from:
* Blended Working
* Bonus
* 25 days holiday plus bank holidays (rising to 28)
* Option to buy holiday days
* Wellbeing Programme
* Health Cash Plan
* Pension
* Life Assurance
* Enhanced Maternity/Paternity
* Cycle to Work Scheme
* Referral Scheme
* Long Service Awards
* Free Parking
ABOUT THE ROLE
Reporting to the Head of Clinical and Regulatory Affairs, this is an exciting opportunity to play an important role within Eakin Healthcare. Expansion and diversification of our product portfolio necessitates a dedicated Clinical Project Manager to support the team in developing innovative medical devices. Working closely with our Research and development, and Commercial teams, you will be responsible for managing multiple projects to validate the clinical efficacy of Eakin Healthcare products. Ideally this role will be based at our Comber site, however applicants based in the Cardiff or Coleraine area will also be considered.
KEY RESPONSIBILITES
Clinical/User Study Design and Delivery
* Design, manage, and report on multiple types of clinical and user studies across international markets
* Design and manage usability/human factors studies across development stages, including engaging with end users when required
* Complete activities to support clinical investigation (where appropriate) of devices within the Eakin Healthcare Group
* Design and manage post-market surveillance activities to assess the device risk profile and support commercial teams to develop areas of product differentiation (e.g., post-market user evaluations)
* Recruit users to grow an international user database for future user trial recruitment
New product development
* Work closely with the R&D and commercial teams to assess the potential clinical and user requirements of new concepts
* Work closely with the R&D and commercial teams to ensure all aspects of the user and clinical pathways are considered during development
* Inform user requirements for development projects
* Manage the usability process for all devices developed by Eakin R&D
* Complete validation activities related to the user experience and clinical outcomes
* Ensure rigorous clinical and user appraisal of all devices developed by Eakin R&D (e.g., literature searches, clinical evaluation)
Regulatory compliance and clinical documentation
* Manage clinical documentation in accordance with relevant regulations
* Remain up to date with impending changes and developments regarding clinical-regulatory compliance
* Provide support to enhance internal understanding of ISO14155
Collaboration and Stakeholder Engagement
* Collaborate with QA/RA functions within the Eakin Healthcare Group and provide clinical support as required
* Build relationships with external agencies to support clinical activities in all countries where Eakin Healthcare products are marketed
* Support other departments within the Eakin Group, including Technical Support, Quality, Sales and Marketing, with advice and guidance on clinical efficacy
* Provide clinical guidance and support to all countries where Eakin Healthcare markets product
Other
* To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
* To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy.
* To adhere to the company's Quality policy and Environmental policy.
* To undertake other duties as may be reasonably required.
WHAT WE'RE LOOKING FOR
Essential
* Degree level qualification (or equivalent)
* Experience in a clinical setting (industry or public sector)
* Experience in questionnaire design/focus group facilitation to collect user feedback in a healthcare setting
Desirable
* Experience within Medical Device Industry either in product design or clinical validation
* Ability to demonstrate regulatory knowledge of medical devices
* Experience in conducting user trials and/or user research activities.
* Experience in conducting human factors studies
* Provide evidence of conducting clinical investigations in EU and US
* Experience of developing an international patient database to support clinical studies
* Fluency in additional European language.
KEY WORKING RELATIONSHIPS
Internal
* Working with Operations and the R&D team to manage clinical activities and provide advice and support to peers
* Collaborating with Commercial functions across Eakin Healthcare Group to support gathering of clinical data for market launch and on-going device marketing activities
* Group wide QA/RA functions to provide clinical support for continuous improvement
External
* Healthcare professionals
* End-users
* Regulatory bodies
* Research agencies
ADDITIONAL INFORMATION
* Ability/willingness to develop within the role
* Ability/willingness to attend training courses in relation to the role and the needs of the department
* Ability/willingness to travel to other Eakin Group sites as needed
COMPETENCIES
Quality Orientation – Is precise, pays attention to details, checks things and ties up 'loose ends'. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn't give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Supporting Others – Enjoys supporting other people and is prone to getting involved and trying to help them when they have problems. Is comfortable to contribute to joint endeavours and enjoys teamwork. Is willing to let other people depend on them.