Clinical Data Management Associate II, Early Phase

Location: Foster City, California US

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Job Number: 1945

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Job Responsibilities:

  • Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, 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, accuracy and consistency of routine clinical data and data structure.
  • Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
  • May lead in the preparation of CRF/eCRF design.
  • 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.
  • 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/EMA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
  • Demonstrates understanding of project timelines and metrics to ensure databases are delivered to set timelines.


Education and Experience:

  • 3 years of experience and a BS degree.
  • 1 year of experience and a MS degree or PhD
  • Early and late phase study experience preferred

For jobs in the United States:

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.

Job Number: R0014685

Community / Marketing Title: Clinical Data Management Associate II, Early Phase

Location_formattedLocationLong: Foster City, California US

 

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