Clinical Scientist, 100%

Vor 6 Tagen


Schlieren, Schweiz LimmaTech Biologics AG Vollzeit

You hold a Master or PhD degree in Life Science or similar and have minimum of three years’ experience in Clinical Development with strong scientific and analytical skills. Demonstrated working experience in an industrial, biomedical research setting would be ideal.

As a Clinical Scientist your responsibilities will include:

- Supporting the Clinical Director in designing clinical trials and regulatory strategies
- Developing the Statistical Analysis plan for the ongoing studies in collaboration with the CRO statisticians. Acting as main point of contact for CRO statisticians
- Identifying, coordinating, and supporting the development of clinical assays with external partners and/or clinical sites
- Analyzing, interpreting, and presenting of clinical data internally and externally
- Conducting data checks, data query and database integrity assignments
- Supporting the preparation and/or review of clinical study documentation
- Developing and maintaining high quality study related documentation, including but not limited to protocol, study plans and clinical study report
- Tracking and managing operational aspects of projects including budgeting, trial master file and risk management
- Identifying, selecting, managing, and overseeing external vendors to ensure performance and deliverables
- Planning and conducting key opinion leader meetings and training sessions, as required
- Coordinating and tracking shipments and databases of clinical trial samples, investigational material or trial related material

You are an efficient and enthusiastic multi-cultural team player with:

- Previous experience in regulatory affairs, documentation to FDA, EMA, etc.
- Experience in planning and managing late-stage clinical trials
- Good statistics background with focus on clinical trials
- Hands-on experience in managing operational aspects of clinical trials and developing all study-related documents
- Excellent planning and communication skills
- In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans
- Ability to work successfully in a biotechnology culture in an entrepreneurial, fast-paced environment, where science-based outcomes matter
- Good verbal and written communication skills in English

The working place is in Schlieren near Zürich, easily accessible by public transportation. If you meet the requirements of this exciting position and want to work in a friendly, highly motivated and dynamic team, we are interested in hearing from you.



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