Associate Manager, Clinical Data Management
Core
Plans and manages end-to-end clinical data management activities for complex human use research activities, ensuring data quality and compliance with GCP regulations.
Role type
Associate Manager, Clinical Data Management
Builds
Complete, high-quality, and reliable clinical trial data for assigned projects
Domain
Healthcare / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management, GCP regulations, CFR, ICH guidelines, Clinical Data Management Systems, Project management, Metrics analysis, Vendor oversight, Study plan authoring, Data quality review
Preferred skills
Mentorship, Cross-functional collaboration, Health Authority inspection support
Technologies
EDC, eCOA, External Data systems
Responsibilities
Plans and manages design and implementation of Data Management tasks; Ensures Data Management activities comply with ethical standards and GCP; Coordinates development of SOPs; Collaborates with Clinical and Biostatistics to improve solutions; Plans and delivers clinical trial data; Provides oversight for third-party vendors; Gathers requirements for EDC and other data collection systems; Enforces data standard conventions; Authors and reviews study documents (Data Management Plan, Edit Check Specifications); Chairs Data Quality Review meetings; Represents DM on cross-functional teams; Supports Health Authority inspections; Evaluates external service provider proposals; Mentors junior professionals.
Seniority
Associate Manager, hands-on leadership with mentorship