JOB ACCOUNTABILITIES:
1. Plan, manage, control, and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
2. Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques. Manage timelines and coordinate activities for assigned projects.
3. Specify database validation checks for assigned studies. Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area-specific modules.
4. Define and monitor clinical trial dataflow and quality control (QC) processes in accordance with corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and QC processes.
5. Design and review patient Case Report Forms (CRFs) and database schema. Test data capture/entry screens.
6. Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area-specific modules.
7. Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study.
8. Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data.
9. Validate and distribute study progress status reports to internal and external study team members.
10. Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures, and medications.
11. Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
12. Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies.
QUALIFICATIONS:
1. A Bachelors’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years’ experience in clinical trial data capture and management, or a Master’s or Ph.D degree in these fields with at least 1 year of relevant experience.
2. Demonstrate an in-depth understanding of clinical trial data management concepts, processes and procedures, and relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
3. Demonstrate a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
Location: Shanghai or Other cities (Remote)