Lead Clinical Study Manager, Oncology Diagnostics Lausanne

Maclivaro Limited; Lausanne; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Confidential in Lausanne seeks a Clinical Study Manager to lead planning, coordination and execution of clinical performance and validation studies for IVDs in oncology. You will work with senior clinical, regulatory and technical stakeholders to ensure timely delivery and adherence to quality and regulatory standards.

In this hands-on, fast-moving role you’ll own clinical programmes across development areas, build processes, and interact with investigators and sites to advance novel diagnostic

Qualifikationen

• Experience designing and coordinating clinical performance/validation studies.
• Knowledge of regulatory requirements for IVD/medical devices.
• Ability to work across clinical/scientific/technical stakeholders.

Aufgaben

• Plan, coordinate and execute clinical performance and validation studies.
• Coordinate sites, investigators, hospitals and CROs.
• Develop study protocols, timelines and documentation.
• Support regulatory submissions and evidence generation.
• Maintain trial documentation and records with quality standards.
• Provide updates to leadership on progress, risks and issues.

Kenntnisse

Clinical studies

IVD experience

Oncology

Regulatory knowledge

Project management

Stakeholder coordination

Documentation

Quality systems

Ausbildung

Master's degree in Life Sciences

Cert. in Clinical Research

Tools

CTMS

eTMF

Jobbeschreibung

Confidential in Lausanne seeks a Clinical Study Manager to lead planning, coordination and execution of clinical performance and validation studies for IVDs in oncology. You will work with senior clinical, regulatory and technical stakeholders to ensure timely delivery and adherence to quality and regulatory standards.

In this hands-on, fast-moving role you’ll own clinical programmes across development areas, build processes, and interact with investigators and sites to advance novel diagnostic