Sr Clinical Operations Specialist

il y a 3 jours


Paris, France Syneos Health, Inc. Temps plein

OverviewLocation: FRA-Paris Job ID: 25101997Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, and we continuously seek ways to simplify and streamline our work. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally and we are dedicated to taking care of our people.We are building a company that values diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging for all.Job ResponsibilitiesResponsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.Creates and assists with maintenance of project files, handles project correspondence.Participates in file audits.Prepares and maintains site manuals, reference tools and other documents.Maintains, updates, and inputs clinical tracking information into databases.Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.Manages shared mailbox, processes site requests and routes correspondence appropriately.Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues.Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.May provide training or mentorship to more junior level Clinical Operations Specialists (COS).QualificationsAssociates degree preferred or equivalentExperience in clinical research/pharma/biotech or related field considered in lieu of degreeGood knowledge of medical terminology, clinical data, and ICH/GCP preferredAbility to successfully prioritize and work on multiple tasksStrong attention to detail, accuracy and organizational skillsExcellent communication, presentation, and interpersonal skillsAbility to embrace new technologiesMinimal travel up to 10% may be requiredGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion with no prior notice. This description does not create a contract of employment. The Company will determine what constitutes as equivalent qualifications. The content is intended to comply with applicable laws and regulations. The Company is an Equal Opportunity Employer and provides reasonable accommodations for disabilities where appropriate.SummaryRoles within Clinical Operations are responsible for ensuring safe and effective operations of clinical research studies and safeguarding the wellbeing of research subjects. They review study protocols, plan and execute procedures, recruit and coordinate communication with clinical trial volunteers and patients, and collaborate with cross-functional teams to monitor trial progress and address issues in compliance with global and regional regulations.At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway and consider transferrable skills. Visit www.syneoshealth.com for more information.EEO and ContactSyneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodations to complete any part of the application process, please contact us at: jobs@syneoshealth.com. #J-18808-Ljbffr



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