Location: Greater Zurich Area | Switzerland
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 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
#J-18808-Ljbffr
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 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
#J-18808-Ljbffr
Clinical Project Manager Arbeitgeber: headcount | recruitment driven by science
Als Arbeitgeber in der pharmazeutischen Industrie bieten wir Ihnen die Möglichkeit, an spannenden IT-Infrastrukturprojekten zu arbeiten, die einen direkten Einfluss auf die Qualität und Sicherheit unserer Produkte haben. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen durch gezielte Schulungen und Entwicklungsmöglichkeiten helfen, Ihre Karriere voranzutreiben. Zudem profitieren Sie von einem dynamischen Arbeitsumfeld, das sowohl lokale als auch globale Perspektiven vereint und Ihnen die Chance gibt, mit führenden Experten der Branche zusammenzuarbeiten.
Kontaktdaten:
headcount | recruitment driven by science Recruiting-Team
