Clinical Research Associate (H/F)
Withings, France
Job Description
Withings is on a mission to be the trusted leader in clinical-grade smart health devices. Already the leading innovator of smart scales, our product portfolio includes connected scales, connected blood pressure monitors, sleep monitors, thermometers, and health/activity wearables.
Today, our products enable a diverse and growing set of innovators in the healthcare industry to better take care of their patients. From chronic condition management to remote patient monitoring and clinical research, Withings has dedicated solutions that provide the richest array of accurate, real-world data, thanks to our complete ecosystem of connected devices, data connectivity options, and our remote patient monitoring platform.
We are looking for a Clinical Research Associate to join our Clinical Operations team.
Missions
- Participate actively in the design phase of clinical investigations by becoming an expert on the device to be tested
- Assist in the development of clinical trial protocols for studies sponsored by Withings, ensuring alignment with regulatory and ethical guidelines
- Stay updated on regulatory requirements and assist in preparation of regulatory package.
- Perform Site Selection visits being able of evaluating if the site is suitable for the study conduction (considering infrastructure, potential team members and technology requirements)
- Conduct site initiation visits, ensuring sites are adequately equipped and trained for data collection and management
- Oversee the day-to-day data consistency check monitoring for ongoing clinical studies
- Collaborate with study sites to identify and recruit eligible participants for the trials, ensuring study protocol compliance
- Conduct regular site visits to monitor the progress of Withings trials, ensuring adherence to protocols and data collection standards.
- Oversee the collection, management, and quality control of e-health data, including remote monitoring and patient-reported outcomes (Data Monitoring)
- Participation in design, development, and execution of databases to collect data for clinical research projects following compliance rules (approved protocol and documentation) and timelines.
- Assist in the preparation of clinical trial reports
- Collaborate with data analysts and statisticians to facilitate data analysis for Withings sponsored studies
- Ensure that trials are conducted in accordance with Good Clinical Practice (GCP) and all relevant Withings standards
- Foster effective collaboration with cross-functional teams, including IT, data management, and regulatory affairs, to ensure successful e-health trial implementation
Requirements
- A minimum of a BA or BS degree in Life Sciences, or related scientific field (or equivalent experience) is required with an additional CRA certification.
- 2 years' successful experience in clinical research within biotech, pharma or CRO industry is preferred
- Regulatory compliance, knowledge of pharmaceutical regulations, good clinical practices, and clinical trial methodology.
- Familiarity with electronic data capture (EDC) systems and e-PRO (patient-reported outcomes) tools.
- You are a dynamic problem-solver with excellent communication skills and a relentless attention to detail.
Benefits
Joining the Withings adventure means :
- Joining one of the world's pioneers and leaders in connected health, winner of several awards at the Consumer Electronic Show,
- Contributing to innovative and ambitious projects for the health of tomorrow in an agile and constantly evolving environment,
- Join an international company, member of the FrenchTech 120, with teams based in Issy-les-Moulineaux, Boston, Hong-Kong and Shenzhen,
- Participate in the continuous improvement of our products and services by beta-testing them before their release, especially during our numerous sports sessions with colleagues,
- Benefit from numerous advantages: Stock Options, smartphone and computer of your choice, discounts for cultural and sports activities, company restaurant, and much more,
- Participate in the Withings Med Academy by attending lectures by healthcare professionals to strengthen your knowledge in the medical field,
- Collaborate with passionate colleagues and celebrate each of our successes together!
At Withings, we know that diversity, equity and inclusivity are paramount to fostering innovation. We rely on the unique skill sets, life experiences and perspectives of each team member to accomplish our missioncreating technology that people love, to make better health part of everyday life.