Clinical Data Management Associate II

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: June 24, 2022

Job Description:

Key Skills:

• May lead a study or group of related small studies.
• Demonstrates the ability to lead a study (ies)/project(s) with minimal supervision.
• Serves as a point of contact for study management team.
• Effectively interact with cross-functional team
• Assists in implementing routine activities involving CDM interaction with other study management team members.
• Reviews study protocols 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 and issues.
• The point of contact for Clinical Research regarding data management issues.
• Demonstrates ability to identify problems early and communicate escalation issues appropriately.Job Responsibilities:
  • Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, Global Patient Safety, 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:
    • 4 years of experience and a BS degree.
    • 2 years of experience and a MS degreeFor 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 for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​For more information about equal employment opportunity protections, please view the poster.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 to apply for this job.jeid-32433bb75779e34e9bc090244868d931

Keywords: Gilead Sciences, Inc., San Mateo , Clinical Data Management Associate II, Healthcare , San Mateo, California