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
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