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sas edc cdisc sdtm veeva📋 Description
- Primary DM contact (Lead DM) for assigned projects; ensure back-up, continuity, responsiveness.
- Oversee project data entry process including guidelines, training, quality and resourcing.
- May perform quality control of data entry.
- Provide input and manage timelines; ensure DM deadlines with quality.
- Develop CRF specifications from protocol and coordinate stakeholder feedback.
- May assist in building clinical databases.
🎯 Requirements
- Bachelors and/or a combination of related experience
- 8+ years' experience
- Excellent organizational and communication skills
- Professional use of English; both written and oral
- Experience with clinical database management systems
- Broad knowledge of drug, device and/or biologic development and data management practices
🎁 Benefits
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
- Oncology and/or Orphan Drug therapeutic experience
- Knowledge of Biostatistics
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