Responsible for executing end to end clinical data management (CDM) activities pertaining to clinical trials, including but not limited to: Oversee the process and quality of data management work contracted to a CRO, perform data integrity review. Develop data management tool and system, perform data management activities, in compliance with Hutchison Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
The Clinical Data Scientist is accountable to:
- Provides early strategic input into protocol design, contracting process focused on data management issues.
- 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.
- Leads the development of eCRFs, database and all the other 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. Lead the development and implementation of new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function.
- Anticipates problems, issues, and delays, and proactively works to minimize the impact.
- Understanding of the conceptual basis for data management conventions, standards and processes.
Ability to develop solutions to complex problems.
- Uses rigorous, objective logic and methods to solve difficult problems with effective solutions.
- Ability to negotiate and strategically influence stakeholders.
- Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical, Inform, RAVE) and understanding of database/programming concepts. Expert in the use of Data Management applications and database/file structures.
- Knowledge of the clinical development process. Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
- Ability to apply advanced principles, theories and concepts for CDM as a whole.
- Knowledge of industry standards and practices, e.g. CDISC.
- Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
- At least 3-year data management experience in a multinational pharmaceutical company or Clinical Research Organization (CRO).
- Fluent oral and written English skills.
- Self-motivated, excellent in work planning and time management.
- 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.