Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist jobs in United States
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Amgen · 2 hours ago

Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist

Amgen is a leading biotechnology company focused on serving patients with serious illnesses. The Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist will work with cross-functional teams to design, implement, and maintain eCOA systems for clinical trials, ensuring adherence to protocols and regulations.

BiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Accountable for quality delivery and competencies within the eCOA service area
Oversee study level system requirements meetings with eCOA vendors and internal stakeholders
Assist in the design and development of study specific technical documents
Support the internal team in managing project related timelines and associated activities
Partner with data management (DM) to define the requirements for data transfers
Work with external resources to manage the creation and execution of user acceptance tests
Identify and track study-related technical issues to resolution
Provide a supportive framework for continuous process and quality improvements

Qualification

Clinical development experienceECOA system implementationClinical Practices knowledgeTechnical expertiseVendor management experienceProject managementProblem resolutionPMP certificationAttention to detailDocumentation skillsCommunication skillsTime managementTeamworkDecision-makingOrganizational skills

Required

Doctorate degree OR
Master's degree and 2 years of clinical experience OR
Bachelor's degree and 4 years of clinical experience OR
Associate's degree and 8 years of clinical experience
High school diploma / GED and 10 years of clinical experience

Preferred

Bachelor's Degree in life science, computer science, engineering, business or related discipline
Experience in clinical development
Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry
Knowledgeable in Good Clinical Practices, and FDA regulations necessary
Project management and technical expertise, attention to detail, and excellent documentation and communication skills
PMP
Previous vendor management experience
Excellent time management and organization skills
Have sound problem resolution, judgment, and decision-making abilities
Be able to work well in a team-based environment with minimal supervision

Benefits

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Company

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

H1B Sponsorship

Amgen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)

Funding

Current Stage
Public Company
Total Funding
$28.5B
2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO

Leadership Team

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Robert Bradway
Chairman and Chief Executive Officer
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Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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Company data provided by crunchbase