Clinical Data Operations Manager

Sonova AG•Santa Clarita, CA

1d•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.
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).

Responsibilities

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.

Benefits

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-ups 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