Clinical Data Team Lead — Trials & Compliance

MMS Holdings Inc

South Africa

Remote

ZAR 900,000 - 1,400,000

Full time

14 days+

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Job summary

MMS Holdings Inc. is seeking a Data Team Lead to drive data management initiatives within our clinical research operations. This role focuses on leading DM activities, ensuring data quality, and coordinating with study teams across multiple sites.

The ideal candidate has 5+ years in data management leadership, strong knowledge of regulatory standards, and hands-on experience with eCRFs and data specs. A collaborative, detail-oriented approach is essential in this fast-paced environment.

Qualifications

Bachelor's degree in scientific, medical, clinical discipline, or related field.
Minimum of 5 years’ experience as a Data Team Lead or similar.
Expert knowledge of scientific principles and concepts.
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred.
Familiarity with ISO 9001, ISO 27001, FDA, and GCP requirements.

Responsibilities

Proficient with MS Office applications.
Understand ICH, 21CFR Part 11, ISO 9001 and ISO 27001.
Develop eCRFs, CRF Completion Guidelines, Edit check specs, and DMP.
Create study tracking and metric reports for the study team.
Oversee CRF tracking, data entry, external data integration, data validation and review, queries, SAE reconciliation, and database QC audits.
Perform UAT of EDC and integrated systems, including test plan/scripts.
Assist with training sites/users on EDC applications and UAT.
Ensure end-user knowledge for study conduct activities including queries management and reporting.
Lead studies or small data management project teams for a client.