Associate Director, Clinical Data Management

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:

Provide program-level leadership for multiple studies, defining and executing global data management strategies.

Drive data strategy, vendor oversight, and process excellence to meet organizational and regulatory expectations.

Manage and mentor a team of data leads, offering performance feedback and supporting professional growth.

Support strategic planning, outsourcing strategy, KPI monitoring, and continuous improvement initiatives.

Implement best practices for validation programs to ensure consistency and compliance across projects.

Clinical Data Operations:

Oversee eCRF design, data review, SDTM development, and database lock for global studies.

Partner with CROs and internal stakeholders to ensure delivery according to timelines and data quality standards.

Collaborate with Clinical Operations, Biostatistics, and vendors to drive efficiency and accuracy.

Maintain compliance with CDISC, ICH GCP, and 21 CFR Part 11 throughout all data processes.

Lead and contribute to the development of departmental SOPs, data standards, and process improvements.

Compliance and Quality Oversight:

Ensure data management activities meet global regulatory and quality standards (FDA, EMA, PMDA).

Support inspection readiness and risk-based quality management (RBQM).

Partner with cross-functional teams to implement data governance frameworks and uphold data integrity.

Apply best practices in clinical data compliance, CDASH, and validation standards such as Pinnacle
21.

Required Skills:

Bachelor’s degree in Life Sciences, Data Science, or related field (advanced degree preferred).

12+ years of clinical data management experience, including 3+ years in leadership roles within biotech/pharma.

Proven expertise in CRO/vendor management, Medidata RAVE, CDISC SDTM, and Pinnacle
21 validation.

Strong understanding of ICH GCP, CDASH, and global inspection processes.

Excellent leadership, communication, and project management skills across global, cross-functional team.

Highly motivated, adaptable, and committed to innovation, quality, and operational excellence.