Clinical Project Manager (Maternity Cover)
ABOUT THE ROLE
Reporting to the Head of Clinical and Regulatory Affairs, this is an exciting opportunity to play an important role in a growing Operations team. Expansion and diversification of our product portfolio necessitates a dedicated Clinical Project Manager (Maternity Cover) to support the team in developing innovative medical devices. Working closely with our Innovation, Development, Mechanical 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 Peterborough area will also be considered.
- Work closely with the R&D Innovation and Development teams to inform user requirements for development projects
- Provide guidance on simulated use testing to develop representative test protocols
- Design, manage, and report on multiple types of clinical and user studies across international markets
- Participate in cross functional product development teams as the clinical representative
- Collaborate with QA/RA functions within the Eakin Healthcare Group and provide clinical support as required
- Support development and implementation of a clinical product development strategy
- Remain up to date with impending changes and developments regarding clinical-regulatory compliance
- Provide clinical guidance and support to all countries where Eakin Healthcare market product
- Manage clinical documentation in accordance with relevant Regulations
- Provide support to enhance internal understanding of ISO14155
Your role as Clinical Project Manager (Maternity Cover) will cover a diverse range of activities but will have focus on ensuring safety and clinical efficacy of all products developed within Eakin R&D. Specifically, you will be expected to:
- Ensure rigorous clinical and user appraisal of all devices developed by Eakin R&D e.g literature searches, clinical evaluation
- Improve internal knowledge of validation activities related to the user experience and clinical outcomes
- Manage the usability process for all devices developed by Eakin R&D
- 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
- Work closely with the innovation team to assess the potential clinical and user requirements of new concepts
- Work closely with the design & mechanical team to ensure all aspects of the user and clinical pathways are considered during development
- Build relationships with external agencies to support clinical activities in all countries where Eakin Healthcare products are marketed
- Recruit users to grow an international user database for future user trial recruitment. Support other departments within the Eakin Group, including Technical Support, Quality, Sales and Marketing with advice and guidance on clinical efficacy.
- 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.
- 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 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.
- Degree level qualification (or equivalent)
- Experience within Medical Device Industry either in product design or clinical validation
- Experience in MDD/MDR, ISO13485 and ISO14971
- Ability to demonstrate regulatory knowledge in Class I and Class IIa of medical devices
- Experience in conducting user trials and/or user research activities such as focus groups.
- Experience in questionnaire design to collect user reported data in a healthcare setting
- Working knowledge of Class IIb and Class III of medical devices
- Experience in conducting human factors studies
- Provide evidence of conducting clinical investigations in EU and US
- Working knowledge of ISO10993
- Experience of developing an international patient database to support clinical studies
- Fluency in additional European language
KEY WORKING RELATIONSHIPS
- 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
- Healthcare professionals
- Regulatory bodies
- Research agencies
- 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
Building strong customer relationships and delivering customer-centric solutions.
Taking a broad view when approaching issues, using a global lens.
Optimizes Work Processes
Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
Effectively building formal and informal relationship networks inside and outside the organization.
Recognising the value that different perspectives and cultures bring to an organisation.
Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Gaining the confidence and trust of others through honesty, integrity and authenticity.
Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder.