Clinical Project Manager
Vor 2 Tagen
To support our Clinical team, we are currently looking for a:
**Clinical Project Manager, 100%**
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 cross-functional 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.
- In-depth 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, 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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