Overview
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.
