Clinical Trial Manager

We are seeking a Clinical Trial Manager (CTM) to support the planning, execution, and oversight of Phase I–III clinical trials outsourced to Contract Research Organizations (CROs). The role ensures that studies are conducted in compliance with ICH-GCP, applicable regulatory requirements, and internal Opterion processes. The CTM will work cross-functionally and serve as a key operational link between Opterion, CROs, and external vendors to ensure high-quality and timely study delivery.

This position reports to the Chief Medical Officer.

Workload: 80% (Hybrid possible; weekly on-site presence required).

Eligibility: Applicants must hold a valid Swiss work permit or otherwise be legally authorized to work in Switzerland. Fluency in spoken and written English is required.

• Participate in CRO selection and ongoing vendor performance assessments.
• Serve as a primary operational contact for CROs and external vendors.
• Develop and implement Vendor Oversight Management Plans (VOMPs).
• Ensure study conduct is aligned with Opterion policies and oversight expectations.

• Contribute to the development of study protocols, project plans, and budgets.
• Support country and site selection activities.
• Assist in planning and coordination of clinical trial supplies.
• Ensure essential documents are in place for site initiation and IMP release.
• Prepare, review, and maintain study documentation (e.g., ISF, monitoring plans, pharmacy manuals, communication plans).
• Support set-up and maintenance of clinical systems (EDC, IRT, eTMF, RACT, etc.).
• Set up and manage study-related SharePoint structures.

• Maintain thorough knowledge of study protocols and procedures.
• Conduct co-monitoring visits and review monitoring reports for quality and consistency.
• Track study progress and prepare status trackers and reports. Regulatory, Compliance & Documentation
  • Maintain timely updates of clinical trial registries.
  • Participate in audits and Health Authority inspections.
  • Support periodic review and development of SOPs and internal policies.
  • Ensure high-quality maintenance of the eTMF, including regular QC checks.
  Pharmacovigilance / Clinical Safety Oversight
  • Support oversight of PV/Clinical Safety vendors and deliverables.
    
    Review and approve trial-specific safety documentation (e.g., Safety Management Plans, SAE forms).
  • Review regular safety status reports.
  • Monitor SAE reporting compliance.
  • Ensure all safety-related documentation is filed in the TMF.
  Cross-Functional Collaboration
  • Coordinate with internal stakeholders to ensure smooth operational execution.
  • Respond in a timely manner to requests from cross-functional teams and external partners.
  Skills and Competencies
  • Master’s degree or equivalent in life sciences, healthcare, or a related field (minimum).
  • 2–3 years of experience in clinical development within the pharmaceutical/biotech industry or at a CRO (required).
  • Experience in clinical monitoring (CRA role) is an advantage.
  • Experience supporting Health Authority inspections (FDA/EMA) is a plus.
    
    Experience in pre-clinical, analytical, or QC settings is beneficial.
  • Solid knowledge of drug development and clinical trial regulations (ICH-GCP, EMA, FDA, local requirements).
  • Strong organizational and time-management capabilities.
  • Ability to work independently while collaborating effectively in a global team.
  • Excellent interpersonal and problem-solving skills.
  • Strong analytical mindset and attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Eagerness and ability to learn quickly.
  • Clear, concise written and verbal communication skills.
  • Fluency in spoken and written English.
  Why Join Us:
  Our Vision is:

  Revolutionizing dialysis care to set a new standard of care in peritoneal dialysis.

  Our Mission is:

  To relentlessly innovate for those living with chronic kidney disease, creating breakthrough therapies that put patients first. We are driven by science, guided by compassion, curiosity, and the belief that every person deserves in a future free from the burdens of outdated treatments.

  You will:
  • Work at the interface of science and clinical development, driving impact on real-world therapies.
  • Collaborate in a cross-functional, international environment that values scientific excellence and teamwork.
  • Receive competitive compensation, professional development opportunities, and a culture focused on integrity and innovation.