Sr Clin Data Mgmt Assoc (Korean Studies)

Location
Foster City, CA
Posted
Jul 21, 2021
Ref
2312572
Required Education
Bachelors Degree
Position Type
Full time
Sr Clin Data Mgmt Assoc (Korean Studies)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Clinical data managers work collaboratively with internal and external colleagues and vendors to support Gilead's business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes
  • 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

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 skills and experience:
  • Experience with post marketing studies
  • Vendor management experience
  • Experience with Korean Post Marketing Surveillance studies
  • Understands Korean and regulations
  • Korean written and verbal skills
  • Experience with DreamCIS and/or PostMaNet EDC systems


Education and experience:
  • 5 years of experience and a BS degree
  • 3 years of experience and a MS degree

Gilead Sciences 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 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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:

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