Laboratory Clinical Data Management Associate II

Location
94404, Foster City
Posted
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:

http://biometrics-careers.gilead.com/

 

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

 

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

 

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

 

For Current Gilead Employees and Contractors:

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

 

To apply, visit: http://apptrkr.com/1306662