Clinical Project Manager H/F
Volta Medical
Volta Medical

Clinical Project Manager H/F

  • Avenue Jules Cantini, Marseille, 13006
    • Other 
    A few days at home
    Education: Not specified
    Experience: > 3 years

    This position was filled!

    Who are they?

    Founded in 2016 in Marseille by three electrophysiologists and a data scientist, Volta Medical aims to improve the treatment of complex cardiac arrhythmias. The company develops and deploys devices based on artificial intelligence.

    Its main product assists cardiologists in treating atrial fibrillation, a condition that affects millions of patients worldwide.

    This technology is CE-marked in Europe and FDA cleared in the USA and has been used in over 1000 procedures in clinical trials across 5 countries and 30 centers.

    With over 80 employees and more than 70 million euros raised to date, Volta Medical focuses on R&D and clinical research to enhance treatments and care strategies for patients with complex cardiac arrhythmias.

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    Job description

    Who are we ?

    The creation of Volta Medical follows the discovery of a new medical approach to aid in the treatment of atrial fibrillation (the most common cardiac arrhythmia in the world) by the company’s founders, world experts in interventional electrophysiology and intracardiac signal analysis.

    Volta Medical is an innovative start-up based in Marseille, whose goal is to provide a range of artificial intelligence-based products to guide the cardiologist during ablation-type procedures.

    We started this adventure 7 years ago and our team now has nearly 70 employees in France, Germany and the United States ! We completed a $27 million Series A round in November 2020 and a $38 million Series B round in January 2023.

    Our values

  • Be a pioneer: Be brave. Don’t be scared of researching, exploring, trying and sometimes failing.
  • Improve patients’ lives: Create products to provide electrophysiologists with the best user-experience possible, to help them improve the lives of patients.
  • Strive for excellence: Push yourselves to deliver the highest quality in everything you do. Learn from your mistakes and aim for the best.
  • Collaborate as a team: Welcome to a multidisciplinary and a diversified team! Try to understand people from different cultures and environments. Confront your ideas and have fun! 

    • Mission

  • The position will report to the Vice-President of Clinical & Regulatory Affairs. 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.
  • Coordinate and monitor all operational aspects of clinical research (pre-market & post-market clinical investigations),
  • Select and manage vendors (CRO, core lab, etc.),
  • Prepare study documents: protocols, amendments, informed consent forms, case report forms, investigator brochure, etc., ensuring regulatory and scientific integrity,
  • Submit the clinical investigation application to appropriate National Authorities and Ethics Committees.
  • Prepare contracts and budgets, working closely with hospitals and investigators participating in clinical trials,
  • Manage safety reporting in clinical investigations,
  • Monitor study progress and report findings,
  • Analyze study data: prepare clinical investigation reports and present data summaries,
  • Write Clinical Evaluation Plans/Reports (CEPs/CERs) and other regulatory documents, as applicable,
  • Participate in the development, review and implementation of clinical SOPs and processes,
  • Cross-functionality assisting Quality and Regulatory Affairs colleagues, as needed.

    • Profile

  • 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 a medical device company or CRO),
  • Solid knowledge of GCPs (Good Clinical Practices), ISO 14155 standard, MDR 2017/745 and GDPR requirements in clinical investigations,
  • Experience with medical writing, CEPs/CERs and clinical investigation reports,
  • Medical device experience mandatory,
  • Fluent in English,
  • Excellent verbal and written communication skills,
  • Scientific background appreciated,
  • Cardiology experience is a plus.
  • Dynamic,
  • Solving problem attitude,
  • Autonomy,
  • Attention to details.

    • Recruitment process

  • Pre-qualification Call with the HR team - 30’ (call)
  • Interview with the VP of Clinical & Regulatory Affairs - 60’ (in person)
  • Technical or situational test (by email)
  • Reference check
  • Cultural Fit Interview with the HR Director and a team member - 60' (in person)

    • What we can offer you at Volta Medical

  •  Passionate colleagues that have the same goal in mind: improve patients’ lives.
  • A corporate culture based on innovation, empowerment and collaboration.
  • An international environment that allows you to practice your best American accent.
  • Prospects of ambitious evolutions with various internal mobilities
  • Regular team building events, breakfasts for gourmands and for the people enjoying sport activities, free weekly yoga classes and preferential rates for a gym subscription.
  • And more traditional advantages: a lunch voucher card (Swile), a good health insurance (Malakoff Humanis), a vacation bonus, RTTs in addition to paid vacation, as well as exceptional days of absence on top of those provided in the collective agreement (compensation hold in case of illness starting from 6 months of seniority, additional days for a sick child, moving leave, etc.)  

    • Join a company on a human scale, whose operations leave room for initiative and innovation in the service of patients.

    The information that you provide is subject to personal data processing by Volta Medical as data controller for the purpose of managing your job application. 

     

    The information provided is for the use of Volta Medical’s recruitment team as well as other recipients (individuals and organizations) involved in the recruitment for the position that you applied for. Your information will be stored for the duration of the processing of your application. If you are not selected for the position, your information will not be stored, unless you consented to being included in our applicant database. In this case, your information will be stored for 2 years from the date of the submission of your application to enable us to contact you for future opportunities. Nevertheless, you have the right to withdraw your consent at any time.

    As part of its activities, Volta Medical may transfer data to a country outside of the European Union with appropriate safeguards in place.

    Volta Medical’s Privacy Policy provides more in-depth details about how your information is used and stored, as well as the legal bases that dictate the information processing that is carried out. The Privacy Policy also includes a reminder of your personal data rights and information on how to reach us with any questions or concerns.

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