Clinical Data Management (Advanced)

We are seeking an experienced Advanced Clinical Data Manager (CDM) to lead and perform complex scientific clinical data review activities across clinical programs. In this role, you will work in close collaboration with Study Responsible Physicians (SRP), Study Responsible Scientists (SRS), and cross-functional teams to ensure high-quality, scientifically robust, and inspection-ready clinical data.

You will play a program-level leadership role, driving data review strategy, ensuring compliance with regulatory requirements (ICH-GCP, SOPs), and contributing to continuous improvement initiatives within Clinical Data Management.

• 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.

• 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.