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Gilead

Sr Clinical Data Management Associate

For Current Gilead Employees and Contractors:

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

Job Description

  • Work collaboratively with global, cross-functional study management teams to support post marketing studies
  • Provide vendor oversight, communicating expectations for study timelines and data quality
  • Provide CDM input during CRO selection process in order to select appropriate CRO by reviewing RFP (request for proposal to CRO) and CRO contract, or by attending CRO selection meeting
  • Review study protocols
  • Ensure completeness, accuracy and consistency of clinical data and data structure through the creation and review of:
    • Case Report Forms (CRF) and CRF completion guidelines
    • Electronic Data Capture (EDC) requirements and specifications
    • Clinical Data Management Plans
    • Data Validation Plans
    • Data Quality Review Plans
  • Provide appropriate guidance to CRO DM personnel to resolve data/query related issues raised by CRO during day-to-day CRF data cleaning
  • Ensure adherence to Gilead processes and local country regulations
  • Korean and/or Japanese written and verbal skills Experience with DreamCIS and/or PostMaNet EDC systems

Essential skills and experience:

  • Demonstrates proficiency in leading studies/projects with minimal supervision
  • Experience working on global cross-functional teams
  • Excellent verbal and written communication skills in English
  • Experience working with EDC systems
  • Understanding of Good Clinical Practice

Preferred but not required experience:

  • Experience of Japanese Post Marketing Surveillance (PMS) studies
  • Understands Japanese regulations, specifically Good Post Marketing Surveillance Practice (GPSP)
  • Experience of PMS re-examination process, including preparation of associated documentation such as the EDC Management Sheet
  • Experience with Fujitsu FIP Post Ma Net EDC system and Medidata Rave EDC system
  • General knowledge of FDA/EMA regulations and with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA is also preferred
  • Vendor management experience

Education and Experience:

  • 5 years of experience and a BS degree.
  • 3 years of experience and a MS degree.
  • 2 years of experience and a PhD

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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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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.

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