Clinical project manager

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 Project Manager, 100%

You have a Master's or PhD degree in life sciences and at least three years of professional experience, preferably in a pharmaceutical or biotechnology company, where you have successfully led and managed clinical trials or programs, ideally in phases I and II.

As a Clinical Project Manager your responsibilities will include:

• Leading and managing clinical trials to ensure adherence to scope, quality, budget, timelines
• Designing regulatory strategy, clinical trial design and development plans with support from the Clinical Director
• Analyzing, interpreting and presenting clinical data internally and externally
• Managing and preparing submissions to ECs, IRBs, and regulatory bodies
• 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 in cross-functional teams, with management or key stakeholders as needed

You are an efficient and enthusiastic team player with:

• Hands-on experience in successfully managing all operational aspects of clinical trials
• Experience in the development of study-related documents like study protocols, interim reports, final study reports, etc.
• Experience in management of CROs, vendors and consultants
• Excellent planning and communication skills
• Good understanding/previous experience in the submission of the study application packages to and the communication with ECs, IRBs and regulatory authorities like EMA, FDA, etc.
• In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans
• Knowledge of statistics and data interpretation
• A desire to work successfully in an entrepreneurial, innovative, fast-paced environment, where science-based outcomes matter
• Good verbal and written communication skills in English

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

If you meet the requirements of this exciting position and want to contribute to our mission, we would love to hear from you. Please submit your detailed application, including a motivation letter, CV, diplomas and reference letters as one PDF file. Incomplete applications will not be considered. Please apply directly via our website, choose the vacancy on the right-hand side and fill in the application form. Please press the “Submit” button to send your detailed application.

Please note that due to visa regulations, only applicants eligible to work in Switzerland can be considered for this position