Specific Responsibilities:
The selected candidate will manage biomarker data in various stages, from planning, to set-up, conduct, closeout, and archiving, in high volume, while maintaining a high level of data quality by leveraging and adhering to standard data structures and corresponding standard edit checks and review listings. The selected candidate may also manage and lead in the design and implementation of biomarker data management processes with vendors, ensuring completeness, correctness, and consistency according to the standards.
Works collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Bio banking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting. Demonstrate a general understanding of each assigned protocol, critical tasks and milestones.
Responsibilities include: assisting in the developing the data transfer specifications, the data mapping specifications, the data quality review plan and the data validation specifications, vendor management, data review and data reconciliation. Assist in implementing routine clinical research projects and standards. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.
Lead clinical data manager with 3 -5 years of Sponsor or CRO or Academic experience
Understanding of clinical data management processes
Project management experience of clinical trials
Communication with cross-functional study team members
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