Amgen
Biomedical
Manager,BiomedicalDataStewardship
Neural analysis suggests this role is
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“Manager, Biomedical Data Stewardship at Amgen. Skills: Biomedical Data Stewardship, Protocol standards, MDR systems. Support global BMDS objectives. Provide subject matter expertise”
What You'll Achieve.
Ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy; Ensure consistent and compliant protocol development across therapeutic areas; Ensure alignment between governed standards and protocol authoring practices; Ensure consistent and timely implementation of approved libraries across studies and programs; Ensure compliance with appropriate protocol; Monitor data entry quality and output success
Industry & Context.
Diagnose and remediate errors when outputs fail
What They're Looking For.
Must Have
Bachelor's degree or higher in computer science, statisticsiostatistics, programming, life science, business administration, or related discipline, or equivalent combination of education and experience, 2+ years knowledge/experience in the Pharmaceuticaliotech industry, 2+ years experience of leading the implementation of clinical data standards in a regulated environment
Nice to Have
Master's degree or higher in computer science, statisticsiostatistics, programming, life science, or related discipline, 2+ years experience leading implementation of Protocol standards in a regulated Clinical Development setting, Drug Development experience (pre-, early, late phase and/or observational studies) in related industries or academic research, Experience in protocol development across early and/or late phase clinical studies, Experience supporting cross-functional governance initiatives, Project planning and management experience, Process improvement and operational effectiveness leadership, Development of policies and SOPs, External visibility (industry committees/forums)
What You'll Do.
Support global BMDS objectives
Provide subject matter expertise
Ensure consistent and compliant protocol development
Liaise with cross-functional teams
Review protocols for compliance
Support development and maintenance of implementation guides
Support metadata repository (MDR) entry
Provide DES expertise to stakeholders
Identify and champion opportunities to improve efficiency
Adhere to Amgen Policies
How You'll Work.
Team & Collaboration
Partnering closely with global BMDS; Cross-functional collaboration; Collaborate with global BMDS leadership; Collaborate cross-functionally with Global Regulatory Writing (GRW), Clinical Development, Regulatory, TA SMEs, Dev IS, and other stakeholders; Liaise with cross-functional teams; Develop and maintain working relationships with key stakeholders
Communication Scope
Demonstrated effective communication skills (written and oral); Ability to influence decision making
Process & Methodology
Project planning, Management experience
Full Job Description
## **Career Category** Scientific ## ## **Job Description** **Manager, Biomedical Data Stewardship (India)** **What you will do** Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing an increasingly critical role in integrated delivery and functional leadership. As Manager, Biomedical Data Stewardship, you will help advance Amgen’s Protocol standards and support MDR needs through India-based execution while partnering closely with global BMDS and cross-functional teams. You will act in support of the Design & Innovation function within the Center for Design & Analysis. This position combines hands-on technical depth and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy. **Responsibilities:** * This role supports global Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration. * Collaborate with global BMDS leadership and cross-functional partners to ensure alignment with enterprise standards strategy. * Provide subject matter expertise in protocol standards, structured authoring, and library implementation to ensure consistent and compliant protocol development across therapeutic areas. * Collaborate cross-functionally with Global Regulatory Writing (GRW), Clinical Development, Regulatory, TA SMEs, Dev IS, and other stakeholders to ensure alignment between governed standards and protocol authoring practices. * Support and champion impact assessments, change control documentation, stakeholder communication, and implementation planning for library updates. * Liaise with cross-functional teams to ensure consistent and timely implementation of approved libraries across studies and programs. * Review protocols to ensure compliance with appropriate protocol libraries; provide feedback and guidance to study teams. * Support development and maintenance of implementat
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