56 applicants

Company

BeiGene · 21 hours ago

Clinical Database QA Engineer I

United States

Full-time

Remote

Entry Level

$34.52/hr - $46.54/hr

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

Act as QA engineer for assigned BeiGene EDC clinical studies

Assist with setting up QA processes and standards

Writing and grooming test case inventory to ensure affective use of testing resources

Familiarity with CDISC standards and experience setting up global libraries

Perform Data Quality reviews

Liaises with the IT and Development groups to ensure tight communication, adequate support and quality deliverables

Generates and maintains all required documentation, including specification versions, test summary reports and validation efforts, in support of database build and maintenance.

Assist with creation of SOPs, WIs and Templates for QA processes.

Troubleshoots issues with EDC, working with the EDC vendor as needed

Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and standards.

Serves on project teams to coordinate and lead QA activities for clinical programming projects

Attends meetings, participates in discussions, uses an analytical approach to problem solving with a focus on quality deliverables

Help test external data loads, custom reports, integrations

Support Audit activities

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical Database QAEDC SystemsCDISC StandardsData Quality ReviewsClinical Data ManagementDatabase DesignProject ManagementSOP CreationFluency in English

Required

Bachelor’s degree in engineering or science

Fluent in English both for verbal and written

Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility

Excellent organizational and analytical skills

High attention to detail and accuracy

Proven problem-solving skills

Demonstrated knowledge of clinical and pharmaceutical drug development process

Experience of clinical databases, clinical data management systems and electronic data capture (EDC)

Knowledge and understanding of clinical database design / study build / data validation and system interoperability

Competent with project management skills

Excellent communication and interpersonal skills

Demonstrated ability to work effectively with internal groups and external partners

Ability to work in a global team environment

Ability to interact effectively with all levels of management

Advanced computer skills

Benefits

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Company

BeiGene

Glassdoor

3.1

BeiGene is a global oncology company.

Founded in 2010

Cambridge, Massachusetts, USA

10001+ employees

https://www.beigene.com

H1B Sponsorship

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Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (28)

2022 (36)

2021 (34)

2020 (22)