Tech Stack

Description

You will manage day-to-day Clinical Data Management activities for clinical trials, define data management strategy, oversee external vendors, and collaborate with cross-functional teams to ensure data accuracy and regulatory compliance. This role is critical to advancing targeted therapies for RAS-addicted cancers.

Requirements

• MS, BS/BA with 12+ years of relevant experience
• Direct experience designing and running early-stage clinical trials
• Knowledge of databases, medical coding, QC processes, and auditing
• Working knowledge of ICH, FDA, and GCP regulations
• Strong leadership, teamwork, communication, and multitasking skills

Responsibilities

• Manage Clinical Data Management activities for all trial phases
• Define project-level data management strategy and ensure data accuracy/completeness
• Oversee external vendors (CROs, EDC vendors) and manage data deliverables
• Lead database development, testing, maintenance, and lock/unlock processes
• Direct and mentor internal data management team members