Role and Responsibilities:
As an Associate Director of Clinical Data Management, you will lead the data management function across multiple global studies, providing both strategic direction and operational oversight.
You will ensure high-quality, compliant clinical data through collaboration, vendor management, and continuous improvement in an outsourced model.
Leadership and Strategy:
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Provide program-level leadership for multiple studies, defining and executing global data management strategies.
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Drive data strategy, vendor oversight, and process excellence to meet organizational and regulatory expectations.
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Manage and mentor a team of data leads, offering performance feedback and supporting professional growth.
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Support strategic planning, outsourcing strategy, KPI monitoring, and continuous improvement initiatives.
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Implement best practices for validation programs to ensure consistency and compliance across projects.
Clinical Data Operations:
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Oversee eCRF design, data review, SDTM development, and database lock for global studies.
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Partner with CROs and internal stakeholders to ensure delivery according to timelines and data quality standards.
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Collaborate with Clinical Operations, Biostatistics, and vendors to drive efficiency and accuracy.
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Maintain compliance with CDISC, ICH GCP, and 21 CFR Part 11 throughout all data processes.
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Lead and contribute to the development of departmental SOPs, data standards, and process improvements.
Compliance and Quality Oversight:
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Ensure data management activities meet global regulatory and quality standards (FDA, EMA, PMDA).
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Support inspection readiness and risk-based quality management (RBQM).
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Partner with cross-functional teams to implement data governance frameworks and uphold data integrity.
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Apply best practices in clinical data compliance, CDASH, and validation standards such as Pinnacle21.
Required Skills:
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Bachelor’s degree in Life Sciences, Data Science, or related field (advanced degree preferred).
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12+ years of clinical data management experience, including 3+ years in leadership roles within biotech/pharma.
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Proven expertise in CRO/vendor management, Medidata RAVE, CDISC SDTM, and Pinnacle21 validation.
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Strong understanding of ICH GCP, CDASH, and global inspection processes.
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Excellent leadership, communication, and project management skills across global, cross-functional team.
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Highly motivated, adaptable, and committed to innovation, quality, and operational excellence.