- Irvine, CA 92602, United States
- United States
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Job description
The Manager, Clinical Data Research will oversee the end-to-end collection and processing of clinical trial data. Leads the data management team, enforces regulatory compliance and ensures databases are designed to deliver clean analysis-ready data sets for statistical analysis. This is a hands-on position supporting our mission to improve patient care through the delivery of high-quality clinical data and evidence generation.
What You Will Do
- Lead and mentor Clinical Data Managers and Clinical Data Specialists, managing resource allocation and study workloads across multiple clinical programs.
- Oversee the design, development, testing, validation, and maintenance of Electronic Data Capture (EDC) systems, electronic Case Report Forms (eCRFs), and edit check specifications.
- Drive data review, validation, and cleaning activities to ensure delivery of high-quality, analysis-ready datasets.
- Manage database build, maintenance, and lock activities, ensuring databases are completed accurately and within study timelines.
- Ensure compliance with applicable regulatory requirements, industry standards, and company procedures, including ICH-GCP and CDISC standards.
- Partner with Clinical Research, Biometrics, Safety, and Clinical Insights functions to define data requirements and resolve complex clinical data issues.
- Serve as the primary data management liaison for external vendors, including central laboratories, imaging vendors, and EDC providers, ensuring accurate external data integration.
- Identify and implement process improvements, leveraging lessons learned across studies to enhance efficiency, quality, and consistency.
What You Need
- Master's degree in a health, science, life sciences, or related field.
- Minimum 8 years of experience in Clinical Data Management within the medical device, pharmaceutical, biotechnology, or related regulated industry.
- Industry experience in medical technology or pharmaceutical organizations.
- Experience leading clinical data management activities across multiple clinical studies.
- Hands-on experience with Electronic Data Capture (EDC) systems and clinical database development.
- Experience with data cleaning, database lock activities, and delivery of analysis-ready datasets.
- Knowledge of ICH-GCP requirements and clinical data management best practices.
- Experience managing external vendors and integrating external clinical data sources.
Preferred
- Experience leading or mentoring Clinical Data Management teams.
- Knowledge of CDISC standards, including SDTM and related data structures.
- Experience supporting global clinical trials.
- Experience with Medidata Rave, Veeva Vault, Merative Zelta, or similar EDC platforms.
- Working knowledge of SAS, R, SQL, or other data analysis tools.
- Experience driving process improvement initiatives within Clinical Data Management.
Posted Date: 07/13/2026 This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
Puerto Rico: $77,700 - $129,500 USD Annual
USN: $89,300 - $148,800 USD Annual
US5: $93,800 - $156,200 USD Annual
US10: $98,200 - $163,700 USD Annual
US15: $102,700 - $171,100 USD Annual
US20: $107,200 - $178,600 USD Annual
US30: $116,100 - $193,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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