Clinical Project Manager, 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 and minimum three years' experience in Clinical Project Management roles with strong project management skills.

Demonstrated working experience in an industrial, biomedical research setting would be ideal.

As a Clinical Project Manager your responsibilities will include:

Leading and managing clinical trials to ensure adherence to scope, quality, budget, timelines and performing regular risk assessments
Designing regulatory strategy, clinical trial design and development plans with support from the Clinical Director
Analyzing, interpreting and presenting clinical data internally and externally. Discussing key findings with statisticians
Managing and preparing ethical and regulatory submissions
Identifying, coordinating and supporting the development of clinical assays with external partners and/or clinical sites. Keeping samples' database and shipments tracking
Conducting data checks, data queries and database integrity assignments
Preparation and/or review of clinical study documentation (including but not limited to protocol, study plans and clinical study report)
Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc. to ensure performance and deliverables
Authoring, revising and/or updating SOPs, Work Instructions and other relevant documents
Supporting general activities of the clinical department and representing it on crossfunctional teams, with management or key stakeholders as needed

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

Hands-on experience in managing all operational aspects of clinical trials and developing all study-related documents
Experience in management of CROs, vendors and consultants
Excellent planning and communication skills
Good understanding/previous experience in regulatory affairs, documentation to FDA, EMA, etc.
Indepth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans
Knowledge of statistics and data interpretation
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.