Clinical Affairs Associate

AliveDx is a global leader in transfusion diagnostics, with over 30 years of experience supporting laboratories through a portfolio of high-quality serological reagent solutions. The Alba product range is trusted by hospitals, blood services, and laboratories to ensure the safety and efficiency of transfusion testing. AliveDx operates across sites in Eysins (Switzerland) and Edinburgh (Scotland).

CLINICAL AFFAIRS ASSOCIATE

We are recruiting for a Clinical Affairs Associate to join our Product Development and Support Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.

The Clinical Affairs Associate is responsible for leading the planning, execution, monitoring and reporting of clinical performance studies for the ALBA product range to support regulatory submissions, product launches and ongoing compliance with applicable regulations.  

This role is pivotal in ensuring that the clinical evidence base for ALBA reagents is robust, current and aligned with evolving scientific and regulatory expectations. The Clinical Affairs Associate will manage assigned studies and be responsible for activities including protocol development, data analysis, coordination with external collaborators and internal departments and preparation of clinical reports and documentation.

JOB DESCRIPTION
The main responsibilities will include:

–   Lead the design, planning and management of clinical performance studies for ALBA products, ensuring alignment with regulatory expectations and departmental priorities. Demonstrates accountability by delivering high-quality outcomes and meeting study timelines.

–   Develop, review and maintain study documentation including clinical protocols, data analysis plans, case report forms (CRFs), clinical study reports and associated technical records in accordance with GCP and all other applicable guidance – instilling trust in the scientific evidence base.

–   Analyse clinical study data and generate summary reports, applying rigorous scientific methodology and attention to detail. Collaborates with internal and external stakeholders to ensure results are clearly presented and support regulatory needs.

–   Coordinate and manage communication with external collaborators, such as study sites or partner organisations and internal stakeholders including Regulatory Affairs, Quality and R&D – building effective teams to achieve shared study goals.

–   Review and update scientific validity documentation to ensure alignment with the latest regulatory guidance and scientific literature, maintaining a current and defensible rationale for the intended use of ALBA products.

–   Support IVDR compliance activities, including responding to queries, supporting technical documentation reviews and ensuring clinical evidence files remain audit-ready and scientifically sound.

–   Contribute to the development and revision of Instructions for Use (IFU) for both new and existing products, ensuring content reflects accurate clinical and technical information and aligns with regulatory requirements – delivering customer-orientated solutions.

–   Assist in preparing for regulatory inspections or notified body reviews related to clinical evidence and documentation, demonstrating responsibility and commitment to compliance.

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

–   Relevant degree or equivalent qualification in a scientific or health-related discipline (e.g., Biomedical Science, Biochemistry, Biology or a field with a strong emphasis on clinical research).

–   Demonstrated experience supporting or leading clinical study activities within the diagnostics or life sciences industry.

–   Understanding of data handling, statistical analysis approaches and good documentation practices.

–   Organised, methodical and detail-orientated, able to manage multiple projects simultaneously.

–   Flexibility to work adjusted hours to meet study timelines or business needs, as required.

–   Occasional travel may be required (e.g., study site visits, regulatory meetings), subject to prior agreement

ADDITIONAL INFORMATION

–   Competitive salary on offer.

–   AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.