Orthopedic Clinical Research Lead — Regulatory & Studies

Medartis AG; Basel; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Medartis AG is seeking a scientifically minded professional to drive clinical research programs in orthopedics, coordinating networks of sites and investigators across regulatory landscapes. The role emphasizes data handling, protocol development, and cross-functional collaboration within a growing international team.

The incumbent will support preclinical and clinical studies, manage communications with study directors, and ensure adherence to ICH-GCP and ISO standards while advancing Medartis

Qualifikationen

• Degree in a STEM field at university level or equivalent professional experience/training.
• PhD and GCP certificate desirable.

Aufgaben

• Cultivate a portfolio of clinical research projects and a network of clinical research sites and investigators to support Medartis business and regulatory requirements.
• Create new and maintain existing customer contacts including visits, trainings and advice as the point of contact between internal and external partners.
• Create new and maintain existing processes within the Medartis quality system ensuring compliance with regulatory and legal requirements.
• Select and support preclinical and clinical studies including patient registries, retro- and prospective studies, case study reviews and pre-clinical modeling.
• Engage study institutions and researchers to participate in studies.
• Coordinate communication with the study director from conception to final report publication.
• Provide support with study protocols, contractual questions and follow up as required.
• Ensure regulatory requirements (IRB, ethics committees, ICH-GCP, ISO 14155, SAE reporting).
• Perform statistical analysis and scientific writing (reviews for publication/presentations).
• Implement digital tools such as databases, EDC solutions, registries, and train study staff.

Kenntnisse

Fluent English

Statistics knowledge

Independent and proactive

Willingness to travel

Strong scientific communication

Ausbildung

STEM degree

PhD desirable

Tools

EDC software solutions

Microsoft Office

Jobbeschreibung

Medartis AG is seeking a scientifically minded professional to drive clinical research programs in orthopedics, coordinating networks of sites and investigators across regulatory landscapes. The role emphasizes data handling, protocol development, and cross-functional collaboration within a growing international team.

The incumbent will support preclinical and clinical studies, manage communications with study directors, and ensure adherence to ICH-GCP and ISO standards while advancing Medartis