Clinical Scientist, 100% - Schlieren, Schweiz - LimmaTech Biologics AG

LimmaTech Biologics AG

Geprüftes Unternehmen

Schlieren, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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 latestage clinical trials
Good statistics background with focus on clinical trials
Handson experience in managing operational aspects of clinical trials and developing all studyrelated documents
Excellent planning and communication skills
Indepth 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, fastpaced environment, where sciencebased 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.