Requirements: English
Company: Excelya
Region: Boulogne-Billancourt , le-de-France
Why Join Us? At Excelya, we combine passion forscience with enthusiasm for teamwork to redefine excellence inhealthcare. Heres what makes us unique We are a young, ambitioushealth company representing 900 Excelyates, driven to becomeEuropes leading mid-size CRO with the best employee experience.Our one-stop provider service modeloffering full-service,functional service provider, and consultingenables you to evolvethrough diverse projects. Working alongside preeminent experts, youwill help improve scientific, operational, and human knowledge toenhance the patients journey. Excelling with care means benefitingfrom an environment that values your natural talents, pushesboundaries with audacity, and nurtures your potential, allowing youto contribute fully to our shared mission. About the Job JoinExcelya, where Audacity, Care, and Energy define who we are and howwe work. We believe in creating bold solutions and fostering aninclusive environment where collaboration and individual growth gohand in hand. This role is an exciting opportunity to contribute toa dynamic, ambitious team in Clinical Operations. You will play acritical part in driving innovation and making an impact in theclinical research space, while enjoying a stimulating professionalenvironment that encourages personal and intellectual growth. Mainresponsibilities : - Qualify, select, and initiate clinicalinvestigation sites in collaboration with the Clinical ProjectManager(s). - Perform site close-out activities in accordance withClinical Project Manager(s)'' recommendations. - Conduct on-site andremote monitoring visits to ensure the scientific quality andaccuracy of collected data. - Serve as the primary point of contactfor investigation sites regarding clinical-related inquiries. -Collaborate with the Data Manager and clinical team to reviewpatient data and ensure data integrity. - Identify non-compliancesand follow up on the implementation of corrective and preventiveactions. - Contribute to study start-up and close-outadministrative tasks, including the preparation of monitoringreports in English. - Participate in project meetings, clinicalprocedure writing and revision, and support audit and inspectionreadiness. About You At Excelya, taking audacious steps isencouraged, so were looking for individuals who are ready to growwith us and share our values. - Experience: Proven ability tothrive in collaborative, fast-moving environments (avoid requiringminimum yearstalent matters most to us!) - Skills: Strongorganizational abilities, problem-solving mindset, and excellentcommunication skills. At least 3 years of experience as a ClinicalResearch Associate (CRA) Regulatory knowledge: ISO 14155, EuropeanMedical Device Regulation 2017/745. Proficient in Good ClinicalPractice (GCP). - Knowledge in cardiology and cardiac surgery is anasset. - Education: Knowledge in Oncology is mandatory - Languages:Fluency in French & good level in English