Clinical Project Manager, 100%

LimmaTech Biologics AG is a clinical stage biopharmaceutical company active in the vaccine and therapeutic fields. In collaboration with GlaxoSmithKline, LimmaTech is developing new generations of antibacterial bioconjugate vaccines against major diseases. We are also actively exploring applications of glycoengineering and protein glycosylation technology in other fields.

To support our Clinical team, we are currently looking for a:

Clinical Project Manager, 100%

You hold a 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 and timelines
• Ensuring the delivery of the clinical study according to ICH GCP (E6-R2), locally applicable regulations and company’s specific SOPs
• Managing and preparing ethical and regulatory submissions
• Managing operational aspects of projects including budgeting, study initiation and risk management
• Developing and ensuring high quality study related documentation
• Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc. to ensure performance and deliverables
• Anticipating potential issues and risks in the clinical trials and creating contingency plans and implementing solutions
• Reviewing clinical data and presenting results internally and externally
• Supporting the Clinical Director in designing clinical trials
• Planning and conducting investigator meetings, training sessions and KOL meetings as required
• Authoring, revising and/or updating SOPs, Work Instructions and additional relevant documents
• Coordinating and tracking shipments and databases of clinical trial samples, investigational material or trial related material
• Supporting general activities of the clinical department and representing clinical in cross-functional teams

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
• Ability to work successfully in a biotechnology culture where a premium is placed on delivering science-based results in an entrepreneurial, fast moving and a sometimes resource constrained environment
• 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.