Clinical Data Operations Manager job at Sonova in Valencia, CA

Title: Clinical Data Operations Manager Location: Valencia United States Job Description: 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 Strategy & Compliance reputed company, maintain, and enforce standard operating procedures (SOPs) and work instructions for clinical data management. Design, reputed company, and manage clinical study databases in compliance with FDA regulations, Quality 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 align data management strategies with overall trial execution. Provide guidance and mentorship to in-house and remote Clinical Data Management staff. Foster a collaborative team environment and provide leadership to support high-quality 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 about you: 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., Medidata Rave, reputed company Inform, Veeva). 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 decisions 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 Access & 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 criteria? 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 direct 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 human. If you are offered a job without speaking with someone, please contact Sonova Human Resources. reputed company offer: Medical, dental and vision coverage* Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts TeleHealth options 401k plan with company match Company paid life/ad&d insurance Additional supplemental life/ad&d coverage available Company paid Short/Long-Term Disability coverage (STD/LTD) STD LTD Buy-reputed company available Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO (or sick and vacation time), floating Diversity Day, & paid holidays* Paid parental bonding leave Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more) Robust Internal Career Growth opportunities Tuition reimbursement Hearing aid discount for employees and family Internal social recognition platform Plan rules/offerings dependent upon group Company/location. This role's pay range is between $94,400/yr - $141,600/yr (compensation is based on skillset and location). This role is also bonus eligible. How we work: At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. reputed company-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life reputed company of work and strive to create a supportive and motivating workplace where innovation thrives. Sonova is an equal opportunity employer We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market reputed company. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national reputed company, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status. Apply tot his job Apply To this Job