Senior Clinical Data Manager — HIV Trial Leader

The Henry M. Jackson Foundation for the Advancement of Military Medicine; Bethesda (MD); In loco; USD 93.000 - 126.000; Tempo pieno

Descrizione del lavoro

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

The role involves overseeing data collection, databases, and analysis workflows while ensuring regulatory adherence. Qualified candidates will have a Bachelor's in Public Health or related field (Master's preferred) and

Competenze

• Bachelor's degree in public health or a related field required; Master's degree preferred.
• More than 10 years of relevant experience.
• Proficiency in clinical trial data management and regulatory knowledge (GCP/ICH, FDA, CDISC).

Mansioni

• Develops and executes all aspects of clinical trial Data Management.
• Manages multiple large studies concurrently.
• Mentors Data Managers and supports DCAC service delivery.
• Oversees data collection forms, databases, edit checks, and analysis datasets.
• Collaborates with investigators and protocol teams to document DCAC requirements.
• May handle budget/planning and travel.
• Ensure regulatory compliance with GCP, FDA, ICH and CDISC.

Conoscenze

Data management

GCP/ICH

FDA/CDISC

Leadership

Regulatory compliance

Clinical trials

Formazione

Bachelor's degree in public health or related field

Master's degree preferred

10+ years of experience

Strumenti

REDCap

OpenClinical

Medidata Rave

Oracle InForm

Oracle Clinical

Descrizione del lavoro

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

The role involves overseeing data collection, databases, and analysis workflows while ensuring regulatory adherence. Qualified candidates will have a Bachelor's in Public Health or related field (Master's preferred) and