Clinical Data Operations Manager

Valencia, CA – Hybrid

Clinical Data Operations Manager

 

 

 

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.

 

 

 

Responsibilities:

Data Management Strategy & Compliance

• 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.
• Data Integrity & Reporting
• Develop 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.

Continuous Improvement & Resource Management

• 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.

 

Travelling Requirement:  up to 20%

 

 

More about you:

• 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 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 all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

 

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier 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.

 

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