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Clinical Operations | Biotechnology | Greater Zurich Area | Switzerland
Our client is an innovative, clinical-stage biotechnology company dedicated to advancing novel therapies for serious infectious diseases and other unmet medical needs. To strengthen their Clinical team, we are currently looking for an experienced Clinical Project Manager to support the planning and execution of early-stage clinical development programs.
Your Responsibilities
As a member of the Clinical team, your responsibilities will include:
- Managing clinical trials to ensure adherence to scope, quality, budget, and timelines
- Preparing high-quality clinical study documentation, including study protocols, study plans, reports, informed consent forms, and clinical manuals
- Proactively identifying risks, assessing their impact, and driving effective mitigation strategies
- Planning and conducting site initiation visits, monitoring visits, investigator meetings, training sessions, and key opinion leader (KOL) interactions
- Managing and preparing ethics committee and regulatory submissions in accordance with applicable requirements and agreed timelines
- Conducting data reviews, resolving data queries, and supporting database quality and integrity activities
- Identifying, selecting, managing, and overseeing external vendors, including Contract Research Organizations (CROs), clinical sites, and central laboratories, to ensure performance and delivery
- Managing clinical trial budgets and supporting contract negotiations to ensure cost-efficient study execution
- Contributing to clinical development plans and regulatory strategies to support program objectives
- Working in compliance with ICH-GCP (E6(R3)), applicable local regulations, and internal procedures
- Presenting clinical data to internal and external stakeholders
- Authoring, revising, and updating SOPs, work instructions, and other clinical documentation
- Supporting general activities within the Clinical department and collaborating with cross-functional teams and key stakeholders as required.
Your Profile
You are a proactive, enthusiastic team player who enjoys working in a collaborative and fast-paced environment and is motivated to deliver high-quality results.
You bring:
- Master’s degree or PhD in Life Sciences or a related scientific discipline
- At least 5 years of experience in Clinical Operations within the pharmaceutical or biotechnology industry
- Proven experience managing clinical trials or clinical programs, ideally Phase I and Phase II studies
- Hands-on experience managing all operational aspects of clinical trials
- Experience preparing study-related documentation, including study protocols, study reports, informed consent forms, and clinical study plans
- Experience selecting and managing CROs, clinical sites, vendors, and external consultants
- Strong planning, organisational, and communication skills
- Good understanding of clinical trial application submissions and interactions with Ethics Committees (ECs), Institutional Review Boards (IRBs), and regulatory authorities such as the EMA and FDA
- In-depth knowledge of ICH-GCP and experience with clinical risk assessment and mitigation planning
- A desire to work in an entrepreneurial, innovative, and science-driven biotechnology environment
- Excellent written and spoken English
- Eligibility to work in Switzerland.
What you get:
- An opportunity to join an innovative clinical-stage biotechnology company developing therapies with the potential to make a meaningful impact on global health
- A collaborative, international, and highly motivated working environment
- A dynamic and entrepreneurial culture with short decision-making processes
- Modern offices in the Greater Zurich area with excellent public transport connections
- The opportunity to contribute directly to the successful development of innovative clinical programs.
Interested? If you are looking for an opportunity to take ownership of clinical studies in an innovative biotechnology environment, we would be pleased to hear from you.
Please submit your CV in English. All applications will be treated with the strictest confidentiality. Only candidates eligible to work in Switzerland can be considered.