Clinical Research Manager

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

At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world’s leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.

Your responsibilities

• 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 to include visits, trainings and advice acting as the point of contact between internal and external partners


• Create new and maintain existing processes within the Medartis quality system ensuring that all processes comply with internal and external regulatory and legal requirements


• Select and support preclinical and clinical studies (including patient registries, retro- and prospective studies, case study reviews, pre-clinical modeling, possible PMA studies, etc.) by


• proactive engagement of study institutions and clinical researchers to participate in studies


• directing communication with the study director from the conception phase until publication of the final report,


• providing support with


• writing of study protocols contractual questions and follow up as required


• regulatory requirements (lRB, ethics committees, ICH-GCP, ISO 14155, SAE reporting)


• statistical analysis and scientific writing (written reviews for publication/ presentations)


• implementation of digital tools such as databases, EDC solutions, registries, (e)CRFs, etc. and training of study staff (nurses, PIs, etc.) on said tools


• supplying study hardware


• coordination with CROs


• preparation and maintenance of TMF and ISF


• support of study site(s) and study nurse(s); e.g., with questions relating to data entry


• visits and/or on-site monitoring of study sites


• timely communication with all relevant regulatory bodies/lRBs


• study follow up and data collection with


• Responsible for the complete development of study protocols that meet FDA clearance standards, maintain the continuum of support documentation to further validate the proper 'Indications for Use' via education and training on the future and existing Medartis product offerings


• Conscientious, careful, punctual, and reliable work approach


• Fast comprehension and ability to quickly familiarize oneself with new subject areas


• Can work independently and motivated in a small group of specialized experts


• Willingness to take initiative and act autonomously


• Demonstrates assertiveness and patience in daily work


• Relationship development in settings of the field, labs, conferences, or dinner meetings


• Conscientious, precise communication


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


• Familiar with logistical and regulatory issues in the field of clinical studies


• Familiarity with the field of orthopedic surgery or orthopedic medical device design preferred


• Knowledge of statistics is advantageous


• Proficient in office applications


• Familiarity with EDC software solutions is advantageous


• Scientific, structured, rigorous, and strategic work approach


• Willingness to travel (up to 20%)


• Fluent (spoken and written) in English, other languages are advantageous

What we offer

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company.

For further information please visit our Website www.medartis.com.