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Clinical Project Manager
vor 2 Wochen
At ONWARD we're looking for a Clinical Project Manager to join our team.
Full-time - Lausanne
**About the job**:
The Clinical Project Manager is part of our Clinical Program Management team, working collaboratively with various internal and external stakeholders to prepare, submit, and execute clinical trials for our medical devices to support its clinical strategy.
You will play a vital role within our innovative and international team, facilitating the preparation, execution, follow-up and analysis of clinical studies for medical devices.
This position requires close collaboration with hospital staff and study partners, serving as a bridge between healthcare facilities and our company.
Your responsibilities encompass building and maintaining strong relationships with investigational sites, providing technical & regulatory support and data insights, and ensuring the highest levels of compliance and proper conduct of studies in accordance with Good Clinical Practice (GCP) standards.
**Responsibilities**- Participate in the Clinical Program Management team activities required for implementation of ONWARD Medical Clinical strategy.
- You lead the preparation, implementation and coordination of clinical studies activities involving active medical devices in hospitals and rehabilitation centers. The studies can be sponsored by ONWARD Medical, by our academic partner NeuroRestore or belonging to the Investigator Initiated studies program using ONWARD Medical technology.
- You provide insights into clinical study design and develop clinical procedure and assessment-specific protocols/work instructions.
- You lead internal trainings for ONWARD Medical field/clinical/therapy development personnel on relevant clinical protocols.
- You collaborate with clinical centers and the ONWARD Medical clinical and regulatory teams to ensure smooth study preparation, enrolment, and data compliance, adhering to GCP requirements.
- You work with the Product Development team to get full technical knowledge into the clinical team and the study centers and inversely bring rehabilitation, clinical know-how, and user feedback to the company.
- You support clinical study data analysis activities and prepare scientific reports for internal and external audiences.
- You provide data insights and support for marketing initiatives and programs.**About you**:
- You have a university master’s scientific/ or technical degree or a phD. Education in Biomedical engineering, life-science or equivalent is a strong advantage.
- You have at least 2-3 years of experience in conducting clinical research studies with Medical Devices under Good Clinical Practice (GCP).
- You demonstrate attention to patient safety and compliance with study protocol. Attitude compliant with the high quality and regulatory requirements associated with a Class III medical device.
- You have medical and scientific writing skills in the field of medical devices. Record of peer-reviewed publications is a plus.
- You communicate fluently in English, both speaking and writing. Knowledge of French or German is an asset.
- You have strong organizational skills, able to work independently and to coordinate activities.
- You have proven strong interpersonal skills both with external and internal customers.
- You can work in a multi-departmental environment as a strong team player.
- You are interested in working in innovative medical device technologies in an international environment and in the field.
- You have a dynamic behaviour, to be aligned with the culture of a young and growing company.
- Ethical person, with positive outlook and pragmatic attitude.
- Represents the ONWARD CODE (values).- Do you want to join our team as our new Clinical Project Manager? Then we'd love to hear about you
