Related skills
sas edc cdisc sdtm adam📋 Description
- Lead DM for assigned clinical projects from start-up to database lock.
- Develop and oversee DM SOPs/WI and regulatory guidelines.
- Manage database development, testing, and quality control.
- Develop CRF specifications from protocol and coordinate stakeholder feedback.
- Train staff on CRFs, EDC, and project items as needed.
- Oversee DM documentation and Trial Master File completeness.
🎯 Requirements
- Bachelor's degree or equivalent and 8+ years' related experience.
- Professional English language proficiency (written and spoken).
- Proficiency with MS Office: Word, Excel, PowerPoint, Outlook.
- Experience with clinical DBMS and data management.
- Knowledge of CDISC standards (CDASH, SDTM, ADaM).
- Strong leadership and interpersonal skills; ability to travel occasionally.
🎁 Benefits
- Remote work available in Mexico.
- Training and development opportunities.
- Travel opportunities to site visits as needed.
- Collaborative, cross-functional work environment.
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