Clinical Project Manager

headcount AG; Zürich; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

headcount AG in the Greater Zurich Area is seeking a Clinical Project Manager to strengthen the Clinical Operations team. You will lead planning and execution of early-stage clinical studies, ensuring compliance with ICH-GCP, timelines, and budgets while collaborating with cross-functional colleagues.

This role offers an opportunity to influence development programs from study design through regulatory interactions, manage CROs and vendors, prepare study documentation, and present data to

Qualifikationen

• Masters or PhD in Life Sciences.
• At least 5 years of experience in Clinical Operations in pharma/biotech.
• Proven experience leading and managing clinical trials or development programs (Phase I/II).
• Hands‑on experience with operational aspects of clinical trials.
• Experience selecting and managing CROs, sites, vendors and consultants.
• Excellent planning, organizational and communication skills.
• Fluent English in verbal and written communication.

Aufgaben

• Manage clinical trials ensuring scope, quality, budget and timelines.
• Prepare high-quality trial documentation (protocols, plans, reports, ICFs, manuals).
• Identify risks and drive mitigation strategies.
• Plan and conduct site initiation/monitoring visits and investigator meetings.
• Oversee ethical and regulatory submissions per requirements and timelines.
• Conduct data reviews and resolve queries; support data integrity activities.
• Manage CROs, sites, laboratories and vendors; oversee performance and deliverables.
• Manage budgets and support contract negotiations for cost-efficient execution.
• Shape development plans and regulatory strategies to meet program objectives.
• Work according to ICH-GCP, local regulations and SOPs.
• Present clinical data internally and externally.
• Author/update SOPs and work instructions; support cross-functional projects.

Kenntnisse

Clinical Operations

Trial management

Vendor management

Regulatory submissions

ICH-GCP

Cross-functional collaboration

English proficiency

Ausbildung

Master’s degree or PhD in Life Sciences

Jobbeschreibung

Location: Greater Zurich Area | Switzerland

For an innovative, clinical-stage biotechnology company in the Zurich area, we are looking for a Clinical Project Manager to strengthen a growing Clinical Operations team.

This is an excellent opportunity to join a science-driven organization developing innovative therapies with global impact, where you will play a key role in the planning and execution of early-stage clinical studies.

Your Responsibilities

• Managing clinical trials while ensuring compliance with scope, quality, budget and timelines
• Preparing high-quality clinical study documentation, including but not limited to 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 interactions
• Managing and preparing ethical 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 such as Contract Research Organizations (CROs), clinical sites, central laboratories and other service providers to ensure performance and deliverables
• Managing clinical trial budgets and supporting contract negotiations to ensure cost-efficient execution
• Shaping and implementing clinical development plans and regulatory strategies to achieve program objectives
• Working in accordance with ICH-GCP (E6(R3)), applicable local regulations and internal SOPs
• Presenting clinical data internally and externally
• Authoring, revising and updating SOPs, work instructions and other relevant documentation
• Supporting the Clinical department in cross‑functional projects and collaborating with key internal and external stakeholders

Your Profile

• Master’s degree or PhD in Life Sciences
• At least 5 years of experience in Clinical Operations within the pharmaceutical or biotechnology industry
• Proven experience leading and managing clinical trials or clinical development programs, ideally Phase I and Phase II studies
• Hands‑on experience managing all operational aspects of clinical trials
• Experience preparing study‑related documents including study protocols, study reports, informed consent forms and clinical study plans
• Experience selecting and managing CROs, clinical sites, vendors and consultants
• Excellent planning, organizational and communication skills
• Good understanding of clinical trial application submissions and communication with Ethics Committees, IRBs and regulatory authorities such as the EMA and FDA
• In‑depth knowledge of ICH‑GCP and experience in clinical risk assessment and mitigation planning
• A proactive, hands‑on mindset and the ability to thrive in an entrepreneurial, innovative and fast‑paced environment
• Excellent verbal and written communication skills in English

What You Can Expect

• The opportunity to contribute to innovative clinical development programs with meaningful scientific impact
• A collaborative, international and highly motivated working environment
• A dynamic biotechnology company with short decision‑making paths and high ownership
• Modern offices in the Zurich area with excellent public transport connections
• The chance to work closely with experienced cross‑functional teams and make a visible impact on clinical development

Interested?

If you meet the requirements of this exciting opportunity and would like to learn more, we would be delighted to hear from you.

Please apply with your CV, motivation letter, relevant diplomas and reference letters (if available). To ensure an efficient review process, we kindly ask you to submit all application documents as one single PDF file. Incomplete applications may not be considered.

Please note: This position is being managed by an external recruitment partner on behalf of our client. By submitting your application, you acknowledge that your application documents may be shared with our client solely for the purpose of the recruitment and selection process.

Please note that due to Swiss employment regulations, only candidates who are currently eligible to work in Switzerland can be considered for this position.