Clinical Data Operations Manager

Clinical Data Operations Manager

Valencia, CA – Hybrid / Remote

Responsible for overseeing the collection, analysis, and interpretation of clinical data to support regulatory submissions, post‑market surveillance, and evidence generation. This role ensures data integrity, 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 complex clinical data into actionable insights that drive product development, market adoption, and patient safety.

• Develop, maintain, and enforce standard operating procedures (SOPs) and work instructions for clinical data management.
• Design, develop, 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.

• Develop reporting strategies for interim and final clinical data analysis.
• Establish reporting frameworks to monitor operational study performance and ensure data consistency across studies.

• 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.

• Participate in resource forecasting and implement process improvements to enhance data management efficiency.
• Stay current with industry trends and evolving regulatory requirements to ensure best practices.
• Support other Clinical Research Department functions as needed to achieve department goals.
• Other duties as assigned by your manager.

up to 20%

• Bachelor’s Degree in a related 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 (EDC) 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 EDC and CTMS systems (e.g., Medidata Rave, Oracle 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 make 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 desirable.
• Familiarity with data visualization and analytics tools (e.g., Power BI, Tableau, Python, R).

A minimum of 200 Mb/sec download and 10 Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• Tele Health 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‑ups available
• Accident/Hospital Indemnity coverage
• Legal/ Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee…