Manager, Clinical Data Research (Remote)
Job Location:
Irvine, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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
- Masters 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.
United States of America Pay Ranges:
Puerto Rico: $77700 - $129500 USD Annual
USN: $89300 - $148800 USD Annual
US5: $93800 - $156200 USD Annual
US10: $98200 - $163700 USD Annual
US15: $102700 - $171100 USD Annual
US20: $107200 - $178600 USD Annual
US30: $116100 - $193400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:
Manager
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
