Senior Clinical Data Manager - HIV Trials & DCAC Leader

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

Bethesda (MD)

On-site

USD 93,000 - 115,000

Full time

9 days ago

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Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is seeking a Senior Clinical Data Manager to lead data management for HIV and other infectious disease studies within DCAC.

The role involves managing staff, coordinating CRF design, data status, and QA plans across clinical trials and observational research. You will ensure regulatory compliance (GxP, FDA/ICH, CDISC), mentor Data Managers, and collaborate with investigators and project teams to deliver timely,

Qualifications

Proficiency in clinical trial data management processes across phases
60},
Ability to manage multiple, complex studies concurrently
Experience with FDA-regulated substances and INDs is preferred
Expert knowledge of GCP, FDA/ICH, and CDISC standards

Responsibilities

Understands, develops, and executes all aspects of clinical trial Data Management including CRF design and data status tracking
Manages multiple complex studies concurrently and mentors data management staff
Ensures data quality through QA plans and regulatory compliance, including FDA/ICH/CDISC requirements
Provides project management for DCAC service delivery across studies and liaises with investigators and protocol teams
Oversees data collection forms, databases, edit checks, and data transfers to clients