Job Title: Manager, Biospecimen Reporting and Automation
Company: Amgen
Location: Hyderabad, India
Job ID: R-238032
Work Location Type: On Site
Category: Research
Date Posted: Mar 05, 2026
Salary: ₹18,00,000 – ₹30,00,000 per year (Estimated)
Job Overview
The Manager, Biospecimen Reporting and Automation is responsible for leading analytics, automation, and reporting initiatives that support biospecimen operations within clinical research. This role focuses on building scalable reporting frameworks, developing automated dashboards, and ensuring data integrity across reporting systems. The manager collaborates with cross-functional teams including Data Management, Clinical Operations, IT, and Quality to ensure reporting outputs align with regulatory requirements and business objectives while reducing manual reporting efforts.
Key Responsibilities
Define and maintain standards for automated reporting, dashboards, and validation processes.
Oversee the development and maintenance of Appendix I reports and other regulated analytics deliverables.
Review and approve dashboards, scripts, and reporting templates before production release.
Ensure compliance with data governance, validation rules, and version control practices.
Act as an escalation point for complex automation failures, data discrepancies, and reporting risks.
Collaborate with Data Management, Clinical Operations, IT, and Quality teams to align analytics with business and regulatory needs.
Deliver monthly KPI and performance reports to R&D Operations leadership.
Identify opportunities to expand automation and reduce manual reporting workloads.
Support regulatory inspections by maintaining documentation, validation records, and analytics traceability.
Manage the development of dashboards tracking SLA adherence, discrepancy trends, shipment health, and study performance.
Oversee SQL query development and automation scripts using Python or equivalent tools.
Ensure proper validation, version control, and governance of reporting logic and templates.
Produce Back Office Study Health Packs including KPIs, exceptions, and action recommendations.
Generate cross-therapeutic-area KPI insights and performance analytics for quarterly business reviews.
Manage the automation lifecycle including requirements gathering, development, testing, validation, release, and monitoring.
Required Skills and Competencies
Advanced SQL querying and data modeling expertise.
Proficiency in Python or similar programming languages for automation.
Experience with BI and visualization platforms such as Power BI or Tableau.
Strong understanding of relational database structures and data dependencies.
Knowledge of validation frameworks in regulated environments.
Ability to translate operational workflows into automated reporting systems.
Strong data visualization and executive-level reporting skills.
Continuous improvement mindset with a focus on digital transformation and automation.
Qualifications
Minimum Requirements:
Doctorate degree, OR
Master’s degree with 3+ years of experience in supplier management or vendor leadership roles, OR
Bachelor’s degree with 5+ years of relevant experience, OR
Associate’s degree with 10+ years of relevant experience.
Additional Requirements:
Strong project management experience.
Excellent written and verbal communication skills in English.
Proficiency with Microsoft Office tools such as Excel, Word, and PowerPoint.
Technical expertise in areas supporting Research, Development, Medical, Regulatory, Safety, or Knowledge Management.
Preferred Qualifications:
7+ years of experience in the life sciences industry, including 4+ years in biopharmaceutical R&D.
Experience overseeing R&D suppliers such as CROs, specialty laboratories, or imaging vendors.
Experience working in global, matrix-based organizations.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Reasonable accommodations will be provided for individuals with disabilities during the job application and interview process.
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