Clinical Scientist

Vor 2 Tagen

Schlieren, Schweiz LimmaTech Biologics AG Vollzeit

LimmaTech Biologics AG is a Swiss clinical stage biopharmaceutical company. We are advancing our proprietary vaccine pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance (AMR) and sexually transmitted diseases. Working at LimmaTech is a unique chance to be part of the development of life saving vaccines.

To support our Clinical team, we are currently looking for a:
**Clinical Scientist (100%)**

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.
- 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

We offer a friendly, highly motivated, and dynamic work environment located in Schlieren, near Zürich. The location is easily accessible by public transportation.

Please note that due to visa regulations, only applicants eligible for a Swiss work permit can be considered for this position.

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