PHARMAFull-time
Study Delivery Associate
HYDERABAD (IN)ONSITEPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Study Coordination & Timeline Management: Set up and maintain study-level trackers, dashboards, and timelines; communicate operational progress and deliverables to Study Delivery Managers; track action items and risk mitigation plans.
Clinical Trial Systems & Data Management: Maintain data integrity across clinical systems including Clinical Trial Management Systems (CTMS) and training trackers; manage system access provisioning for study teams, investigators, and suppliers.
Document Management & TMF Compliance: Assist in the preparation, quality review, and version-controlled maintenance of study documents, informed consent forms (ICFs), regulatory submissions, and monitoring plans; support Trial Master File (TMF/eTMF) filing and audit readiness.
Study Start-Up & Logistics Operations: Support site engagement, investigator meeting logistics, global site communications, biological sample shipment/reconciliation, and investigational product (IP) tracking.
Inspection Readiness & Quality Reviews: Participate in risk and quality reviews, ensure full completion of mandatory study team trainings, and sustain regulatory compliance with global health authority standards.
Technical & Domain Standards
Strong foundational knowledge of clinical trial lifecycle, ICH-GCP guidelines, and Standard Operating Procedures (SOPs).
Proficiency with clinical trial operational software including CTMS, eTMF, EDC, and Microsoft Office tools.
Total Rewards & Culture
High-impact operational role supporting innovative biotechnology and life-saving clinical trials globally.
Competitive compensation package, annual performance incentives, comprehensive healthcare coverage, and structured professional development pathways.
REQUIRED VERIFIED SKILLS
Clinical Trial Coordination
CTMS
eTMF
ICH-GCP
Study Start-Up
Informed Consent Forms (ICF)
Document Management
Clinical Logistics
Inspection Readiness
Data Entry
COMPENSATION & REWARDS
₹4.5L - 8.5L per annum
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/2
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