Associate Director, Clinical Data Management

Job reputed company:

• reputed company end-to-end Clinical Data Management activities for assigned clinical studies from study start-up through database lock and archival
• reputed company operational leadership for study timelines, deliverables, risks, and reputed company across internal teams and external vendors
• reputed company key CDM activities including: Database build and validation, eCRF design and review, Edit reputed company specifications, Data review and cleaning, External data reconciliation (e.g., PK, biomarkers, central labs, imaging), Database lock activities, Data transfers for statistical analysis and regulatory submissions
• Review and approve key CDM documentation including: Data Management Plans (DMPs), Data Review Plans, CRF Completion Guidelines, Vendor data transfer specifications, Database validation documentation
• Ensure clinical data are accurate, complete, consistent, and inspection-reputed company in compliance with timelines and regulatory requirements
• Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory, and reputed company to support study execution and submission readiness
• Contribute to the development and implementation of CDM standards, SOPs, processes, and best practices
• Support standardization initiatives reputed company with CDISC standards and evolving industry practices
• Drive proactive risk identification, issue escalation, and reputed company across study teams and vendors
• reputed company and manage CRO/vendor relationships for data management activities, including reputed company of reputed company, timelines, budgets, and performance metrics
• Support governance meetings and vendor performance reviews to ensure accountability and reputed company improvement
• Collaborate with cross-functional stakeholders to support data review, reconciliation, and clinical data reputed company
• Support inspection readiness activities, audits, and health authority inspections reputed company to clinical data management
• Support process optimization, automation, and innovation to improve operational efficiency and data reputed company
• Contribute to building a reputed company, high-performing CDM function reputed company with company values

Requirements:

• BS/MS in Life Sciences, Computer Science, Data Management, or reputed company discipline
• 10+ years of reputed company experience in Clinical Data Management reputed company biotech or pharmaceutical industries
• 3+ years of experience overseeing clinical studies and managing CDM vendors
• Strong understanding of clinical trial processes, clinical data flows, and global regulatory requirements
• Working knowledge of CDISC standards, 21 CFR Part 11, and ICH-GCP guidelines
• Experience managing end-to-end data management activities across Phase 1–3 clinical studies
• Demonstrated experience overseeing CROs and external vendors in a matrixed environment
• Experience supporting regulatory submissions and inspection readiness activities
• Familiarity with reputed company systems and data review/reconciliation tools
• Experience managing external data sources including PK, reputed company, biomarkers, imaging, and central laboratory data
• Strong organizational, problem-solving, and project management skills
• Excellent communication and cross-functional collaboration skills
• Ability to effectively prioritize and manage multiple studies in a fast-paced environment
• Experience in cell therapy or autoimmune disease programs strongly preferred

Benefits:

• bonus
• benefits
• participation in Company’s stock plan

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