Job description
Provide operational and scientific support for global clinical validation and research studies under the guidance of the Director of Clinical & Scientific Affairs. Key responsibilities include supporting protocol development, study reports, scientific conference deliverables (posters and presentations), and regulatory documentation while collaborating cross-functionally to ensure rigorous and timely study execution.
Proactively contributes to clinical study processes by supporting the execution and tracking of clinical operations, ensuring compliance with company SOPs, ICH-GCP guidelines, regulatory requirements, and patient safety standards.
Assists in developing and writing clinical study protocols, study plans, Ethics/IRB submission packages, CRFs, and clinical study reports.
Facilitates training for clinical study teams according to study protocols and maintains strong relationships with investigators and external experts to support effective project delivery.
Supports data quality initiatives and helps implement activities required for timely, high-quality deliverables (e.g., collaborating with statisticians and data managers, participating in data review).
Analyzes, interprets, and presents clinical study results to internal and external stakeholders, including contributing to scientific peer-reviewed publications.
Requirements: Graduate student in the advanced stages of PhD (optional MD) in Life Sciences, Biomedical Engineering, or a related discipline.
Previous experience in conducting medical device or IVD clinical studies - Significant advantage.
Knowledge of oncology, pathology, medical device/IVD clinical development, and a deep understanding of molecular pathways and biopharma development in oncology - Preferred.
Experience contributing to research planning, study design, clinical operations, data handling, biostatistics, scientific posters, presentations, and manuscript drafting.
Demonstrated ability to work both independently and collaboratively to execute complex study plans, protocols, methodologies, and study timelines under general guidance.
Solid understanding of the clinical operations value chain, with a proven track record of supporting study planning, execution, data management, and clinical study reporting.
This position is open to all candidates.