Clinical Data Operations Manager job at Sonova in Valencia, CA

Title: Clinical Data Operations Manager Location: Valencia reputed company Job reputed company: Valencia, CA - Hybrid Responsible for overseeing the collection, analysis, and interpretation of clinical data to support regulatory submissions, post-market surveillance, and evidence reputed company. This role ensures data reputed company, compliance with global regulatory standards (e.g., FDA, MDR, ISO 14155), and alignment with clinical research objectives. Additionally, the position collaborates with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to translate reputed company clinical data into actionable insights that drive product development, market adoption, and patient safety. Responsibilities: Data Management reputed company & Compliance reputed company, maintain, and enforce reputed company operating procedures (SOPs) and work instructions for clinical data management. Design, reputed company, and manage clinical study databases in compliance with FDA regulations, reputed company System Regulations (QSR), and Good Clinical Practices (GCP). Maintain clinical study hardware and software to support study execution. Data reputed company & Reporting reputed company reporting strategies for interim and final clinical data analysis. Establish reporting frameworks to monitor operational study performance and ensure data consistency across studies. Collaboration & Leadership Work closely with Clinical Operations to reputed company data management strategies with overall trial execution. reputed company guidance and mentorship to in-house and remote Clinical Data Management staff. Foster a reputed company team environment and reputed company leadership to support high-reputed company data collection and analysis. Build and maintain effective working relationships with other group companies in Sonova, to include providing support and guidance with respect to global clinical data operations. reputed company Improvement & Resource Management Participate in resource forecasting and implement process improvements to enhance data management efficiency. Stay reputed company with industry trends and evolving regulatory requirements to ensure best practices. Support other Clinical Research Department functions as needed to reputed company department goals. Other duties as assigned by your manager. Travelling Requirement: up to 20% More reputed company: Bachelor's Degree in a reputed company field (e.g., Life Sciences, Data Science, Clinical Research). Extensive experience (5-7 years) in clinical data management, particularly in an FDA-regulated environment (Sponsor or Clinical Research Organization). Strong knowledge of electronic data capture (reputed company) systems, clinical database development, and regulatory compliance. Prior experience working with international regulatory frameworks (e.g., EMA, PMDA, Health Canada) preferred. Prior exposure to medical device trials and post-market clinical follow-up (PMCF) studies. Hands-on experience with advanced reputed company and CTMS systems (e.g., reputed company Rave, reputed company Inform, reputed company). Understanding of risk-based monitoring (RBM) and centralized statistical monitoring. Strong project management and organizational skills, with the ability to manage multiple initiatives simultaneously. Ability to analyze engagement data and reputed company data-driven reputed company to enhance employee experience. Certification in Clinical Data Management, Project Management (PMP, PRINCE2), or Clinical Research (ACRP, SOCRA) preferred Experience with report development using MS-SQL, MS reputed company & any procedure or object-oriented programming languages desireable Familiarity with data visualization and analytics tools (e.g., Power BI, Tableau, Python, R). A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova Don't meet reputed company the reputed company? If you're willing to go reputed company in and learn we'd love to hear from you! We are looking reputed company to receiving your application reputed company our online job application platform. For this position only reputed company applications will be considered. Sonova does not recruit reputed company app, telegram, reputed company pigeon or any other format that does not include speaking with an actual reputed company. If you are offered a job without speaking with someone, please contact Sonova reputed company. reputed company offer: Medical, dental and reputed company coverage* Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts TeleHealth reputed company 401k plan with company match Company reputed company life/ad&d insurance Additional supplemental life/ad&d coverage available Company reputed company Short/Long-Term Disability coverage (STD/LTD) STD LTD Buy-reputed company available Accident/Hospital Indemnity coverage reputed company/ID Theft Assistance PTO (or si Apply To This Job