Clinical Data Management Lead
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Work for a Leading US Pharmaceutical Company with Rich Development Pipeline
Take Leadership in all Clinical Data Management Activities for Assigned Trial
About Our Client
- Global pharmaceutical company, with rich development pipeline in immunology, oncology and neurology areas
Job Description
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Responsible for Data Management strategy, planning, execution of activities of assigned TA. Ensure the quality of clinical trial database, and deliver timely, accurate & secure database for clinical development of the analysis.
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Reviews the trial protocol, designs the Case Report Forms (CRF), sets up the trial database and defines and programs the plausibility checks based on project standards and additional trial requirements as needed. Together with the Clinical Trial Lead (CTL) and the Trial Statistician(TSTAT), the TDM initiates and compiles the Trial Data Management Plan (DMP) that contains all the necessary CDM documentation for a trial.
- During the conduct of the trial the TDM is responsible for monitoring the data entry, discrepancy management and for cleaning (completeness, plausibility and consistency) of the data according to the respective SOPs. The TDM is responsible for integration of external data from vendors or other departments into the clinical trial database. The TDM initiates the Medical and Quality Review Plan (MQRP) and supports Medical and Quality Review Meetings (MQRM) together with the CTL and TSTAT in order to assess patients' safety and to monitor the data flow and quality throughout the conduct of the trial.
- During the conduct of the trial the TDM is responsible for monitoring the data entry, discrepancy management and for cleaning (completeness, plausibility and consistency) of the data according to the respective SOPs. The TDM is responsible for integration of external data from vendors or other departments into the clinical trial database. The TDM initiates the Medical and Quality Review Plan (MQRP) and supports Medical and Quality Review Meetings (MQRM) together with the CTL and TSTAT in order to assess patients' safety and to monitor the data flow and quality throughout the conduct of the trial.
The Successful Applicant
Sufficient level of English and Japanese to be able to communicate fluently with other functions
Experience in the following areas:
- Contributing to project/trial team as a team member
- Preparation or review specifications and/or programs
- Oversight of CROs/ IT Vendors
- Communication with PMDA, especially in eData submission
- Regular meetings with other regions BI colleagues
Soft skills:
- Logical thinking and problem solving skill is expected
- Open mindset for diversity and inclusion
What's on Offer
- Expand your career as a clinical data management expert