Clinical Affairs Associate

Our client is looking for a Clinical Affairs Associate

Client Details

A leader in their field

Description

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.
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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.
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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.
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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.
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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.
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Support IVDR compliance activities, including responding to queries, supporting technical documentation reviews and ensuring clinical evidence files remain audit-ready and scientifically sound.
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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.
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Assist in preparing for regulatory inspections or notified body reviews related to clinical evidence and documentation, demonstrating responsibility and commitment to compliance.
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Support laboratory activities related to clinical studies, if qualified, including sample logistics, instrument coordination or limited hands-on testing as needed, demonstrating flexibility and teamwork.
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Promote continuous improvement and innovation by identifying areas for process optimisation and sharing insights to improve clinical study operations and evidence generation practices.
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Actively participate in departmental meetings, knowledge sharing and training, cultivating innovation and contributing to the professional development of self and others.

Profile

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.
Familiarity with GCP, ISO 14155, IVDR and relevant clinical study standards

Strong written and verbal communication skills, including experience preparing clinical study documentation.
Proficiency with Microsoft Office tools (Word, Excel, Outlook, Powerpoint).
Understanding of data handling, statistical analysis approaches and good documentation practices.

Job Offer

A competitive salary and great benefits