Lead Data Manager

该职位来源于猎聘

Job Purpose Lead Data Manager (LDM) needs to lead DM team to deliver the output of DM function within timeline with good quality under the supervision of DMPL in the study.

Roles & Responsibility

• Responsible for creating the main DM documents for EDC set up, including to not limited to o

The study Rave build specification (RBS) based on the study RDS (Raw data specification) and study protocol.

o

Visit Matrix o

Edit check specification o

CRF Completion Guidance o

Coding associated document o

Manual data review specification

• Leads the study specific testing of EDC during the study set up stage and database amendment process.
• Drafts Data Management Plan under the guidance of DMPL.
• Works with DB programmer and external vendor on the external data transfer specification.
• Responsible of routine data management activities e.g., EDC user account management, DM status report, local lab management, DM documentation filing, etc.
• Leads the data validation process in the study and ensures the DM activities to be on track, which includes but not limited to external data reconciliation, SAE reconciliation, coding, etc.
• Performs quality control of the data validation done by DM throughout the study.
• Collaborates with CRA to analyze the data issue trend at site and then supports on the systematic data issue solution.
• Coordinates the medical data review process and manages the stakeholders of medical data review.
• Proactively identifies the risk of data validation and works out the mitigation plan.
• Organizes the data validation activities and creates the data cleaning plan to fit the study needs.
• Generates the Data Management Report (DMR) in China submitted study.
• Contributes on the functional initiative to streamline the process and improves the efficiency.

Job Requirement

Education

• Master’s degree or bachelor’s degree in medical or pharmacy related major Experience:
• 2-3 years of independent experience of Lead DM
• Good knowledge of clinical trial and GCP and regulatory requirement in terms of data management systems and activities Qualification and Skills:
• Fluent English skill
• Proactive communication with others
• Can do attitude
• Good presentation skill
• Certificated SCDM is preferred