Clinical Data Management (Advanced)

Job Description:

Responsibilities

• Lead and execute complex scientific clinical data review at both trial and program levels.
• Collaborate closely with SRP/SRS to review data, resolve eDC queries, and ensure data accuracy and completeness.
• Oversee data flows and Data Management Plans while performing continuous, in-depth data review activities.
• Contribute to protocol design and provide input into eCRFs and data collection tools.
• Align data review expectations and timelines with SRP/SRS, GDM, CROs, and cross-functional stakeholders.
• Define data quality standards, conventions, and ensure timely delivery of all CDM milestones.
• Develop and maintain key documents such as the Integrated Review Plan, ensuring regulatory compliance.
• Ensure inspection readiness and actively support audits and health authority inspections.
• Provide program-level leadership by supporting DMLs in planning, resource allocation, and cross-functional collaboration.
• Drive quality and continuous improvement by implementing best practices and leading process, system, and tool enhancements

Qualification & Experience

• Bachelor’s degree in Life Sciences or related field with 5+ years of Clinical Data Management experience, including strong expertise in scientific data review.
• Solid experience in clinical drug development with deep understanding of data flows, data review processes, and ICH-GCP regulatory requirements.
• Proven leadership capabilities at study or program level, with experience in stakeholder and resource management.
• Strong collaboration skills with the ability to work effectively with physicians, scientists, CROs, and global cross-functional teams.
• Proficiency in eDC and clinical data systems, combined with strong analytical, communication, and problem-solving skills and a quality-driven, continuous improvement mindset.