KEY ACCOUNTABILITIES

Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: perform data management activities in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of data management work contracted to a CRO, perform data integrity review.

The Clinical Data Scientist is accountable to:

• Serves as member of study team and is accountable for all DM-related communications, specifications and documentation, including CRF design, DMP/ECS/CCI development, UAT, data cleaning, Management of local lab reference ranges, Management of external data, Medical coding, SAE reconciliation, Database lock, etc.
• Oversee the process and quality of data management work contracted out to a CRO or research collaborator. Be responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals.
• Proactively communicates with project team to share project status, risk assessment and outstanding item resolution status. Ensures compliance to standard key performance indicators according to process.
• Support all the DM activities for the study handled internally by interacting with other functional area representatives.
• Ensure the TMF maintenance of Data Management is on time with good quality.
• Continually evaluates data management processes and applications for improvements.

Complexity:

• Understand conceptual basis for data management conventions, standards and processes.
• Anticipates problems, issues, and delays, and proactively works to minimize the impact.

Specialised Knowledge:

• Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts.
• Knowledge of the clinical development process.
• Knowledge of industry standards and practices, e.g. CDISC.

Minimum Requirements:

• Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
• At least 1-year data management experience in pharmaceutical company or Clinical Research Organization (CRO)
• Fluent oral and written English skills

Preferred Requirements:

• Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
• Able to work under pressure and in a changing environment with flexibility
• Good communication skills with the ability to communicate with both the technical and business areas.
  
  

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