This role will immediately assume study lead data management responsibilities for 3-5 concurrent clinical trials, utilizing primarily the Medidata RAVE electronic data capture and management system. The selected candidate will manage trials 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 (within the EDC system and in SAS). The selected candidate may also manage and lead in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency according to the Gilead standards. This role has a high degree of collaboration with the Clinical Operations team members, the EDC system staff, the Statistical Programming group, the Biostatistics group, the Biometrics Applications Development group, cross-functional study management team members, and other Clinical Data Associates.
The ideal candidate will posses a BS degree in a Biomedical Science or equivalent and minimum 6 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or bio/pharmaceutical setting.
Essential Duties and Job Functions:
Works collaboratively with CRA, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Demonstrates a general understanding of each assigned protocol, critical tasks and milestones. Ensure completeness, correctness and consistency of routine clinical data and data structure. Responsibilities include: assisting in the implementation of routine clinical data management process with CRO including data entry, data quality checking, data transfer, reporting, backup, and recovery. Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process. Assists in implementing routine clinical research projects. Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.
Knowledge, Experience and Skills:
3 years of experience and a BS degree.
1 years of experience and a MS degree or PhD
Gilead - 15 months ago
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