Senior Data Team Lead (South Africa, Home-Based)
RemoteSouth Africa
Job Summary
Lead the entire data management process from study set-up to close-out, serving as the primary contact for clients and internal management on all data management issues. Conduct protocol reviews to suggest database capture strategies, create training exercises, and mentor new clinical data managers. Provide oversight for CRF tracking, data entry, external data integration, validation, query resolution, adverse event coding, and database lock audits. Develop study documentation including Case Report Forms, CRF Completion Guidelines, Database Design, and Data Management Plans. Prepare tracking reports, oversee user acceptance testing, and lead data management initiatives with minimal management oversight. Work independently to resolve issues while ensuring compliance with GCP, ICH, FDA, and ISO standards.
Required Qualifications
- College graduate in scientific or healthcare field discipline or related field
- 8+ years' experience in data management field
- minimum of 3 years' experience leading projects
- Expert knowledge of scientific principles and concepts
- Intermediate SAS or other relevant programming skills
- extensive experience in relational databases
- Extensive knowledge of paper CRF study systems
- Extensive knowledge of EDC
- Extensive knowledge of hybrid CDM systems
- Extensive knowledge of Clinical Operations SOPs and WPs
- Excellent verbal and written communication skills
- interpersonal skills
- organizational skills
- Proficiency with MS Office applications
- Hands-on experience with clinical trial and pharmaceutical development
- Excellent problem-solving skills
- Good organizational skills
- Familiarity with 21 CFR Part 11
- Familiarity with FDA requirements
- Familiarity with GCP requirements
- This position is a home-based role out of any location in South Africa
Desired Qualifications
- masters preferred
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Familiarity with current ISO 9001 and ISO 27001 standards preferred
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