Remote Pharmaceutical Data Manager — Global Trials

Placements24

Klerksdorp

Hybrid

ZAR 550,000 - 900,000

Full time

11 days ago

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Job summary

Placements24 is seeking a remote Pharmaceutical Data Manager to oversee the design, validation, and integrity of clinical databases across international trials. The role emphasizes GCP/21 CFR Part 11 compliance, SDTM/ADaM familiarity, and collaboration with global teams from home.

You will implement DMPs, supervise data cleaning, and ensure timely data delivery for regulatory submissions while managing multiple studies in a remote, globally distributed environment.

Qualifications

  • 5+ years of clinical data management experience in pharma/biotech.
  • Experience with EDC systems and data validation techniques.
  • Knowledge of regulatory requirements (GCP, 21 CFR Part 11).
  • Familiarity with CDISC standards is desirable.

Responsibilities

  • Design, build, and manage clinical databases using EDC systems.
  • Develop and implement data management plans (DMPs) for clinical trials.
  • Create and maintain data validation specifications, edit checks, and data review guidelines.
  • Perform data cleaning, including query generation, resolution, and reconciliation with external data sources.
  • Oversee the UAT of clinical databases and tools.
  • Ensure compliance with regulatory requirements (GCP, 21 CFR Part 11) and SOPs.
  • Collaborate with clinical operations, biostatistics, programming, and medical writing teams.
  • Generate data management reports and supervise data archiving timelines.

Skills

Analytical thinking
Problem solving
Attention to detail
Communication skills
Time management
Remote work discipline

Education

Bachelor's degree in Computer Science, Statistics, Bioinformatics, Pharmacy or related field
Master's degree in related field (preferred)

Tools

Medidata Rave
Oracle InForm
Veeva EDC

Job description

Placements24 is seeking a remote Pharmaceutical Data Manager to oversee the design, validation, and integrity of clinical databases across international trials. The role emphasizes GCP/21 CFR Part 11 compliance, SDTM/ADaM familiarity, and collaboration with global teams from home.

You will implement DMPs, supervise data cleaning, and ensure timely data delivery for regulatory submissions while managing multiple studies in a remote, globally distributed environment.

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