Clinical Project Manager, 100%

LimmaTech Biologics AG in Schlieren seeks a Senior Clinical Project Manager to lead clinical trials for vaccine development against antimicrobial resistance and STDs, ensuring regulatory compliance and operational excellence.

This position serves the Clinical team at LimmaTech Biologics AG, a Swiss biopharmaceutical firm focused on advancing vaccines targeting antimicrobial resistance and sexually transmitted diseases. The role is central to executing clinical programs that support the company's scientific objectives.

Responsibilities

• Oversee clinical trials to guarantee compliance with scope, budget, quality standards, and schedule.
• Create and maintain high-quality clinical study documentation, such as protocols, reports, informed consent forms, and manuals.
• Identify potential risks, evaluate their impact, and implement effective mitigation strategies.
• Plan and execute site initiation and monitoring visits, investigator meetings, training sessions, and interactions with key opinion leaders.
• Prepare and submit ethical and regulatory applications in line with local regulations and timelines.
• Review data, resolve queries, and support activities that ensure database integrity and quality.
• Select, manage, and oversee external vendors, including CROs, clinical sites, and central laboratories, to ensure deliverables are met.
• Manage clinical trial budgets and negotiate contracts to maintain cost efficiency.
• Develop and implement clinical development plans and regulatory strategies to achieve program goals.
• Ensure all activities adhere to ICH-GCP (E6(R3)), local laws, and company SOPs.
• Present clinical data to internal teams and external stakeholders.
• Draft, revise, and update SOPs, Work Instructions, and related documents.

Requirements

• Master’s or PhD in Life Sciences.
• Minimum five years of experience in clinical operations, ideally within pharma or biotech.
• Proven track record of leading clinical trials, preferably Phase I and II studies.
• Hands-on experience managing all operational aspects of clinical trials.
• Experience developing study documents, including protocols, reports, and informed consent forms.
• Experience selecting and managing CROs, sites, vendors, and consultants.
• Understanding of clinical trial application submissions and communication with ECs, IRBs, EMA, and FDA.
• Deep knowledge of ICH-GCP and experience in risk assessment and mitigation planning.
• Strong verbal and written communication skills in English.

Nice to have

• Prior experience in the pharmaceutical or biotechnology industry.
• Experience with Phase I and II clinical studies.

What the company offers

• A friendly, multi-cultural, and dynamic work environment in Schlieren, near Zürich.
• Easy access via public transportation.

About the company

LimmaTech Biologics AG operates in an entrepreneurial, innovative, and fast-paced environment where science-based outcomes are prioritized. Employees have the unique opportunity to contribute to the development of life-saving vaccines.

• Opportunity to contribute to life-saving vaccine development.
• Entrepreneurial, innovative, and fast-paced work culture.
• Focus on science-based outcomes.

How to apply

Documents to submit:

• Motivation letter
• Diplomas
• Reference letters