Sr. Clinical Data Associate
Gilead - Seattle, WA

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This role will immediately assume study lead data management responsibilities for 3-5 concurrent oncology 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. Previous work in oncology clinical trials is highly desirable.

Essential Duties and Job Functions:
Works collaboratively with CRA, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure. Responsibilities include: ensuring effective communication with vendors with a general understanding and expectation in terms of study timelines and milestones. May lead in the design and implementation of clinical data management process with CRO including data entry, data quality checking, data transfer, reporting, backup, and recovery. May lead in the design of CRF/eCRF for sound and thorough data collection through the regulatory approval process. Assist in the planning and implementation of the data management portions of clinical research projects. Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves non-routine queries. Utilizes reports to track study progress and ensure timeliness and quality expectations are met.

Knowledge, Experience and Skills:
Typically requires 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, or a MS degree minimum 4 years of relevant industry experience. Excellent verbal and written communication skills and interpersonal skills are required. Experience with relational database design, general knowledge of FDA regulations and with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA is also required. Must have excellent communication, problem solving and people/project leadership skills.

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