Clinical Data Operations Manager (Medtech)

TL;DR

Clinical Data Operations Manager (Medtech): Overseeing the collection, analysis, and interpretation of clinical data to support regulatory submissions, post-market surveillance, and evidence generation with an accent on data integrity, compliance with global regulatory standards and alignment with clinical research objectives. Focus on translating complex clinical data into actionable insights that drive product development, market adoption, and patient safety.

Location: Valencia, CA – Hybrid / Remote

Salary: $94,400/yr - $141,600/yr (compensation is based on skillset and location). This role is also bonus eligible.

Company

At Sonova, we envision a world where everyone can enjoy the delight of hearing.

What you will do

• 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 regulations.
• Develop reporting strategies for interim and final clinical data analysis.
• Provide guidance and mentorship to in-house and remote Clinical Data Management staff.
• Participate in resource forecasting and implement process improvements to enhance data management efficiency.
• Support other Clinical Research Department functions as needed to achieve department goals.

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.
• 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.
• Hands-on experience with advanced EDC and CTMS systems (e.g., Medidata Rave, Oracle Inform, Veeva).
• Strong project management and organizational skills, with the ability to manage multiple initiatives simultaneously.

Culture & Benefits

• Medical, dental and vision coverage.
• 401k plan with company match.
• Robust Internal Career Growth opportunities.
• Tuition reimbursement.
• Hearing aid discount for employees and family.
• Hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management.