Associate Director, Clinical Data Management

A company is looking for an Associate Director, Clinical Data Management.

Key Responsibilities

Oversee clinical data management activities for multiple studies, including eCRF development, data cleaning, and database lock

Manage and mentor a team of direct reports, providing performance feedback and career development guidance

Collaborate with internal stakeholders and external vendors to ensure compliance with data standards and support risk management activities

Required Qualifications

BS / BA with at least 12 years of data management experience in the biotechnology / pharmaceutical industry, including 3 years in management

Extensive experience in CRO / vendor management and managing direct reports

Experience leading data management process improvement initiatives and managing global studies through Phase 3

Knowledge of CDISC SDTM data standards and experience with Medidata RAVE EDC system

Expert understanding of industry regulations, including ICH GCP and 21 CFR Part 11