Study Delivery Associate – Amgen
Location
Hyderabad, India
Job Type
Full-time (On-site)
Department
Clinical Development
Experience Required
0–3 years of experience in Clinical Research, Clinical Operations, Clinical Trial Coordination, or Life Sciences-related roles.
Candidates with experience in biotech, pharmaceutical, or CRO clinical trial environments are preferred.
Minimum 1 year of biopharmaceutical clinical research experience is preferred for experienced candidates.
Estimated Salary Package (Market Standard)
₹6 – ₹10 LPA (approx.), depending on experience, clinical trial knowledge, and interview performance.
Job Overview
The Study Delivery Associate provides administrative and operational support to clinical trial management teams by assisting with study coordination, documentation, clinical systems management, regulatory compliance activities, and operational tracking. The role ensures accurate execution of clinical trial processes, supports study timelines, and helps maintain inspection readiness across global clinical studies.
Key Responsibilities
Clinical Study Coordination
Support study setup, tracking, and maintenance of project timelines, dashboards, and trackers.
Communicate study progress, milestones, and deliverables to Study Delivery Managers.
Track study actions, risks, and mitigation activities.
Support risk and quality review documentation.
Ensure completion of study team training and compliance activities.
Assist with investigator meetings, global site communications, and study-related logistics.
Support study start-up activities, including:
Clinical system setup
Supplier access management
Informed Consent Form (ICF) tracking
Document readiness activities
Clinical Operations Support
Support vendor coordination and site engagement activities.
Manage biological sample shipments, reconciliation, and tracking.
Coordinate investigational product logistics and accountability processes.
Assist clinical teams with operational requirements throughout the study lifecycle.
Clinical Data & System Management
Maintain clinical trial systems including:
Clinical Trial Management System (CTMS)
Electronic Trial Master File (eTMF)
Electronic Data Capture (EDC)
Perform accurate and timely data entry.
Support user access requests and system access management.
Maintain study trackers and operational databases.
Document Management
Prepare, review, and maintain clinical study documentation.
Support regulatory submission documents and study materials.
Assist with monitoring plans, study guides, and essential documents.
Support TMF filing activities.
Ensure documents are version-controlled and inspection-ready.
Process Improvement
Participate in process improvement initiatives.
Share knowledge and best practices across study teams.
Identify operational issues and support timely resolution.
Contribute to maintaining quality and consistency across clinical studies.
Educational Qualification
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Healthcare, or a related discipline.
Alternative Qualifications:
Associate degree with 4 years of clinical execution experience.
High school diploma/GED with 6 years of relevant clinical execution experience.
Required Skills
Understanding of clinical trial processes and clinical operations.
Knowledge of regulatory requirements and clinical research workflows.
Familiarity with ICH-GCP guidelines.
Experience managing clinical documentation and essential trial files.
Working knowledge of:
CTMS
eTMF
EDC systems
Clinical trial tracking tools
Strong proficiency in Microsoft Office:
Word
Excel
PowerPoint
Strong organizational and documentation skills.
Ability to manage multiple priorities and timelines.
Good communication and collaboration skills.
Ability to work effectively with global and cross-functional teams.
Strong attention to detail and problem-solving ability.
Preferred Qualifications
Experience working in a Pharmaceutical, Biotechnology, or CRO environment.
Experience supporting global clinical trials.
Knowledge of investigator documentation and regulatory submissions.
Experience with site management, trial startup activities, and vendor coordination.
Familiarity with clinical trial data flow and protocol compliance.
Work Environment
On-site role based in Hyderabad.
Collaboration with global clinical development teams.
Involves coordination with clinical operations, vendors, investigators, and cross-functional stakeholders.
Who Should Apply
Clinical Trial Assistants (CTA), Clinical Research Coordinators (CRC), Study Coordinators, Clinical Operations Associates, and Life Sciences graduates interested in clinical development careers.
Suitable for professionals looking to grow in Clinical Trial Management, Study Delivery, Clinical Operations, and Global Biopharmaceutical Research.
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Remote, India | Siliguri |Illinois :
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