Remote Clinical Data Manager - Trials Quality & Integrity

Placements24; Soweto; Hybrid; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Remote work stipend

Health benefits

Professional development

Flexible schedule

Autonomy in remote environment

Zusammenfassung

Placements24 is seeking a Remote Clinical Data Manager to lead end-to-end data management for international clinical trials. You will oversee database design, UAT, CDMPs, and data validation to ensure high-quality data for regulatory submissions.

The role requires 4+ years in clinical data management, strong CDMS/EDC experience (Medidata Rave, Oracle InForm), and a solid grasp of CDISC SDTM with GCP/ICH guidelines. This is a fully remote position supporting global studies.

Qualifikationen

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 4 years of experience in clinical data management within pharma/biotech.
• Proficiency with clinical data management systems (CDMS) and EDC platforms (e.g., Medidata Rave, Oracle InForm).
• Solid understanding of clinical trial processes, data standards (CDISC SDTM), and regulatory requirements.
• Experience developing data validation checks, managing data queries, and performing database lock.

Aufgaben

• Oversee design, development, and UAT of clinical databases and EDC systems.
• Develop CDMPs and data collection guidelines.
• Define data validation procedures and write validation specs.
• Manage data cleaning, including queries, resolution, and tracking.
• Ensure data management activities comply with GCP, ICH, and SOPs.
• Collaborate with CRAs, statisticians, and programmers to ensure data quality.

Kenntnisse

CDMS

EDC platforms

GCP

Data validation

Query management

Analytical skills

Ausbildung

Bachelor's degree in science/healthcare

Tools

Medidata Rave

Oracle InForm

CDISC SDTM

Jobbeschreibung

Placements24 is seeking a Remote Clinical Data Manager to lead end-to-end data management for international clinical trials. You will oversee database design, UAT, CDMPs, and data validation to ensure high-quality data for regulatory submissions.

The role requires 4+ years in clinical data management, strong CDMS/EDC experience (Medidata Rave, Oracle InForm), and a solid grasp of CDISC SDTM with GCP/ICH guidelines. This is a fully remote position supporting global studies.