About the role & responsibilities
• Act as subject matter expert for Clinical Data Management across global clinical trials
• Review clinical protocols, CRF design, CDASH and CDISC compliance
• Lead database design, edit checks, listings, dashboards and reconciliation plans
• Manage CDM project timelines, deliverables, budgets and client coordination
• Ensure SOP, GCDMP and regulatory compliance across studies
• Maintain audit-ready TMF and CDM documentation
• Mentor CDM teams and develop training and best-practice materials
• Drive process improvement, SOP updates and adoption of new CDM technologies
Qualification
• Graduate degree in Life Sciences / Pharmacy / Biotechnology / Clinical Sciences
Experience
• 8+ years in Clinical Data Management
• Minimum 4 years in a Senior CDM role in CRO or pharma
Skills
• EDC systems and database validation
• CDISC standards (CDASH, SDTM)
• Data reconciliation and inspection readiness
• TMF, GCDMP and regulatory compliance
• Client and stakeholder management
• Team leadership and mentoring
About the company
• Novotech is a leading global CRO delivering end-to-end clinical trial services across multiple therapeutic areas
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