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Clinical Trials Specialist
Il y a 3 mois
Withings is dedicated to leading the way in clinical-grade smart health technology. As a prominent innovator in the realm of smart scales, our diverse product lineup encompasses connected scales, blood pressure monitors, sleep tracking devices, thermometers, and health/activity wearables.
Our offerings empower a wide array of innovators in the healthcare sector to enhance patient care. From managing chronic conditions to facilitating remote patient monitoring and conducting clinical research, Withings provides tailored solutions that deliver a comprehensive suite of accurate, real-world data through our integrated ecosystem of connected devices, data connectivity options, and remote patient monitoring platform.
We are seeking a Clinical Research Associate to become an integral part of our Clinical Operations team.
Key Responsibilities
- Actively engage in the design phase of clinical studies by developing expertise in the device under evaluation.
- Assist in crafting clinical trial protocols for Withings-sponsored studies, ensuring compliance with regulatory and ethical standards.
- Stay informed on regulatory requirements and aid in the preparation of regulatory submissions.
- Conduct Site Selection visits to assess the suitability of sites for study execution, considering infrastructure, potential team members, and technology needs.
- Lead site initiation visits, ensuring that sites are properly equipped and trained for data collection and management.
- Oversee daily data consistency checks for ongoing clinical studies.
- Collaborate with study sites to identify and recruit eligible participants, ensuring adherence to study protocols.
- Perform regular site visits to monitor the progress of Withings trials, ensuring compliance with protocols and data collection standards.
- Manage the collection, oversight, and quality assurance of e-health data, including remote monitoring and patient-reported outcomes.
- Participate in the design, development, and execution of databases for clinical research projects, adhering to compliance rules and timelines.
- Assist in preparing clinical trial reports.
- Work closely with data analysts and statisticians to facilitate data analysis for Withings-sponsored studies.
- Ensure trials are conducted in accordance with Good Clinical Practice (GCP) and all relevant Withings standards.
- Promote effective collaboration with cross-functional teams, including IT, data management, and regulatory affairs, to ensure successful implementation of e-health trials.
Qualifications
- A minimum of a BA or BS degree in Life Sciences or a related scientific field (or equivalent experience) is required, along with an additional CRA certification.
- Preferred experience includes 2 years in clinical research within the biotech, pharmaceutical, or CRO sectors.
- Knowledge of regulatory compliance, pharmaceutical regulations, good clinical practices, and clinical trial methodologies.
- Familiarity with electronic data capture (EDC) systems and e-PRO (patient-reported outcomes) tools.
- A dynamic problem-solver with excellent communication skills and meticulous attention to detail.
Benefits
Being part of Withings means:
- Contributing to one of the world's leading companies in connected health, recognized with multiple awards at the Consumer Electronics Show.
- Engaging in innovative and ambitious projects that shape the future of health in a dynamic and evolving environment.
- Working in an international setting, as a member of the FrenchTech 120, with teams spread across various locations.
- Participating in the continuous enhancement of our products and services through beta-testing, particularly during our numerous team sports activities.
- Enjoying various benefits, including stock options, a choice of smartphone and computer, discounts for cultural and sports activities, and more.
- Participating in the Withings Med Academy by attending lectures from healthcare professionals to deepen your medical knowledge.
- Collaborating with passionate colleagues and celebrating our collective achievements.
At Withings, we recognize that diversity, equity, and inclusivity are essential for fostering innovation. We depend on the unique skills, life experiences, and perspectives of each team member to fulfill our mission—creating technology that people love, making better health an integral part of everyday life.
