Laboratory Clinical Data Management Associate II

94404, Foster City
Oct 25, 2018
Required Education
Bachelors Degree
Position Type
Full time

Laboratory Clinical Data Management Associate II


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


Job Description

Specific Job Responsibilities:

• Works collaboratively with Clinical Programmers, Biostatisticians, Study Team Lead Data Manager and other Clinical, DSPH, Regulatory and Project staff to meet project deliverables and timelines for Central, Local and Bioanalytical data acquisition, quality checking and reporting.

• Demonstrates a general understanding of each assigned protocol, critical tasks and milestones for managing and monitoring lab and PK data.

Ensure completeness, correctness and consistency of routine laboratory data and data structure.

• Implements routine laboratory data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.

• Assists in the preparation of CRF/eCRF for laboratory data collection through the regulatory approval process.

• Reviews study protocol and assists study team, 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.

• Excellent verbal and written communication skills and interpersonal skills are required.

• The ability to problem solve and have people/project leadership skills.

• Knowledge of FDA regulations, laboratory and specimen management functions, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems


Specific Education & Experience Requirements:

3 years of experience and a BS degree.

1 years of experience and a MS degree or PhD


Meet the team:


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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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