Clinical Data Mgmt Manager jobs in United States
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Amgen · 11 hours ago

Clinical Data Mgmt Manager

Amgen is a biotechnology company dedicated to serving patients living with serious illnesses. The Clinical Data Management Manager will ensure timely quality delivery of data management components, lead the development and implementation of processes, and contribute to the continuous improvement of the data management organization.

BiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Ensure a focus on timely quality delivery, as well as consistency across the Data Manager (DM) components
Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners and external vendors
Promote and be an advocate of DM internally and externally
Communication and escalation of project level issues including processes, timelines, resourcing, performance
Assist with response to questions and findings from Clinical Quality Assurance and other audits at the study and vendor level

Qualification

Data Management PlansElectronic Case Report FormsData Cleaning ActivitiesRegulatory ComplianceRegulatory SubmissionsCross-Functional CollaborationArchivalDocumentationCommunication SkillsProblem-Solving Skills

Required

Bachelor's degree (or foreign equivalent) in Business Administration or related field
3 years of experience in the job offered or in a clinical data management-related occupation
Developing and implementing data management plans (DMP) for clinical trials, including data collection, validation, and quality control strategies
Overseeing the design and development of electronic case report forms (eCRFs) and clinical trial databases
Leading data cleaning activities to rectify identified issues and discrepancies
Ensuring data management activities comply with regulatory guidelines, including Good Clinical Practice (GCP) and CDISC standards
Preparing and contributing to regulatory submissions and audits
Collaborating with cross-functional teams, including clinical researchers, biostatisticians, and clinical monitors, to ensure data quality and accuracy
Performing documentation and archival in electronic Trail Master file (eTMF)

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