Associate Director, Clinical Data Management

📋 Description

• Oversee comprehensive Clinical Data Management responsibilities for assigned clinical trials, from study initiation through to database closure and archival.

• Provide strategic leadership on study timelines, deliverables, risk management, and quality assurance across both internal teams and external partners.

• Supervise essential CDM tasks such as: Database construction and validation, eCRF design and assessment, Edit check specifications, Data evaluation and cleansing, External data reconciliation (including PK, biomarkers, central labs, imaging), Database closure processes, Data transfers for statistical analysis and regulatory submissions.

• Review and authorize critical CDM documentation, including: Data Management Plans (DMPs), Data Review Plans, CRF Completion Guidelines, Vendor data transfer specifications, and Database validation documents.

• Ensure that clinical data is precise, complete, consistent, and ready for inspection, while adhering to timelines and regulatory standards.

• Collaborate cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Regulatory Affairs, and Quality Assurance to facilitate study execution and readiness for submission.

• Play a role in the development and execution of CDM standards, SOPs, processes, and best practices.

• Assist in standardization efforts aligned with CDISC standards and emerging industry practices.

• Proactively identify risks, escalate issues, and facilitate resolutions across study teams and vendors.

• Lead and manage relationships with CROs/vendors for data management activities, ensuring oversight of quality, timelines, budgets, and performance metrics.

• Support governance meetings and vendor performance evaluations to maintain accountability and foster continuous improvement.

• Work alongside cross-functional stakeholders to assist in data review, reconciliation, and ensure clinical data integrity.

• Aid in preparation for inspections, audits, and health authority assessments related to clinical data management.

• Support initiatives for process enhancement, automation, and innovation to boost operational efficiency and data quality.

• Contribute to the establishment of a collaborative, high-performance CDM function that aligns with company values.

⛳️ Requirements

• BS/MS in Life Sciences, Computer Science, Data Management, or a related field.

• Over 10 years of progressive experience in Clinical Data Management within the biotech or pharmaceutical sectors.

• More than 3 years of experience supervising clinical studies and managing CDM vendors.

• Strong comprehension of clinical trial processes, clinical data flows, and global regulatory standards.

• Proficient understanding of CDISC standards, 21 CFR Part 11, and ICH-GCP guidelines.

• Experience managing comprehensive data management activities across Phase 1–3 clinical studies.

• Proven track record of overseeing CROs and external vendors within a matrixed environment.

• Experience aiding regulatory submissions and readiness for inspections.

• Familiarity with EDC systems and tools for data review/reconciliation.

• Experience managing external data sources, including PK, ADA, biomarkers, imaging, and central lab data.

• Excellent organizational, problem-solving, and project management capabilities.

• Strong communication skills and ability to collaborate across functions.

• Capability to effectively prioritize and manage multiple studies in a dynamic environment.

• Experience in cell therapy or autoimmune disease programs is highly preferred.

🏝️ Benefits

• Bonus opportunities.

• Comprehensive benefits package.

• Participation in the Company’s stock plan.