Clinical Project Manager H/F

Marseille /
CLQARA – Clinical /
CDI statut cadre
Volta Medical is an AI medtech startup. Volta has developed the first AI software to guide physicians in atrial fibrillation (AF) treatment during a curative intervention called ablation. With 11 million patients in the EU alone (14-17 million in 2030) and 33 million patients worldwide, AF is the most common arrhythmia (irregular heart rhythm) in adults and ablation is currently one of the most advanced treatment options.
After 15+ years of research, Volta Medical has developed a product using a data-driven approach for optimal real-time identification of dispersion zones during atrial fibrillation ablation. This solution is built on artificial intelligence (AI, deep and machine learning) approaches to gain insight into innovative therapies for AF. 
Volta is based in Marseille and has international presence in the USA and Europe. Our mission is to provide a range of intelligent and innovative softwares that will guide the cardiologist during interventions in the operating room. We have recently raised our series A round and the team now consists of more than 30 collaborators with a branch in the United States. We embarked on this adventure more than four years ago and are entering another phase of rapid growth.
At Volta Medical we believe in maintaining high standards, agility and proactivity in our work. We have a multicultural team, embracing diversity and gender balance at the workplace.

We are looking for a Clinical Project Manager to be part of our Clinical team. Solid experience in Clinical Research for Medical Devices is mandatory. The position will report to the VP Clinical & Regulatory Affairs.

Responsibilities

- Coordinating and monitoring all operational aspects of clinical research trials/projects,
- Working with CROs as needed,Preparing study protocols, amendments and study reports, ensuring regulatory and scientific integrity,
- Working closely with hospitals and investigators participating in clinical trials,
- Writing Clinical Evaluation Reports (CERs) and other regulatory documents, as applicable,
- Participating in the development, review and implementation of clinical SOPs and processes,
- Cross-functionality assisting Quality and Regulatory Affairs colleagues, as needed. 

Required Experience

    • Relevant education background (master’s degree),
    • Solid background in project management and in clinical trials/projects (minimum 3 years of experience as clinical project manager in medical device company or CRO),
    • Solid knowledge of GCPs (Good Clinical Practices) and clinical research regulations and standards (ISO 14155),
    • Experience with medical writing, CERs and clinical reports,
    • Medical device experience mandatory,
    • Fluent in English,
    • Excellent verbal and written communication skills,
    • Cardiology experience appreciated.

Soft Skills

    • Dynamic
    • Problem solving attitude
    • Attention to detail
Why should you join?
AI is supposed to revolutionize healthcare in the coming years and we are at the forefront of this revolution.
You will get an opportunity to understand the systemic challenges and the areas of impact that AI can have in healthcare,
You will get an opportunity to work with a highly diverse, motivated, and experienced team,
Opportunity to experience the Mediterranean lifestyle. It is great if you enjoy nature and the ocean! 

Additional Information
The position is on CDI, based in Marseille 6th (on the 17th Floor of a Tour Méditerranée). 

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