Amgen, a global biotechnology leader, is hiring a Study Delivery Associate for its Clinical Research Operations team in Hyderabad, India. This role is ideal for professionals with experience in clinical trial coordination, CTMS, TMF management, and global clinical operations who are looking to work on innovative, patient-centric studies.
As a Study Delivery Associate at Amgen, you will provide critical administrative and operational support to global clinical trials, ensuring regulatory compliance, data accuracy, and timely study delivery. This opportunity offers hands-on exposure to Risk-Based Quality Management (RBQM), study start-up activities, and cross-functional collaboration in a world-class biotech environment.
Key Responsibilities – Study Delivery Associate
Study Planning & Coordination
- Develop and maintain study trackers, dashboards, timelines, and operational tools
- Coordinate logistics for investigator meetings, site communications, and trial events
- Support study start-up (SSU) activities including system access, document readiness, and compliance checks
Study Execution & Oversight
- Monitor global enrollment, data flow, and quality metrics using dashboards and reports
- Support and lead assigned RBQM activities, including risk assessment and mitigation planning
- Track study progress and resolve operational issues with Study Delivery Managers and vendors
- Support global recruitment and retention strategies
Stakeholder & Site Engagement
- Act as a key point of contact for routine study updates
- Collaborate with internal teams, CROs, vendors, and investigator sites
- Identify, prioritize, and escalate study risks in a timely manner
Data, Systems & TMF Management
- Maintain accurate data in CTMS, eTMF, and other clinical systems
- Support query resolution, reconciliation, and data quality checks
- Ensure TMF inspection readiness and version-controlled documentation
Process Improvement
- Contribute to process optimization, automation, and best-practice sharing
- Support CAPA activities and implementation of lessons learned across studies
Qualifications & Experience
Basic Qualifications
- Bachelor’s degree OR
- Associate degree with 4 years of clinical execution experience OR
- High School Diploma/GED with 6 years of clinical execution experience
Preferred Qualifications
- Minimum 2 years of experience in life sciences or a medically related field
- At least 1 year of biopharmaceutical clinical research experience
- Experience working on global clinical trials
- Hands-on knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Key Skills & Competencies
- Strong understanding of clinical trial operations and compliance
- Experience in TMF filing, protocol documentation, and regulatory records
- Excellent coordination, communication, and problem-solving skills
- Ability to work effectively in global, cross-cultural teams
- High attention to detail and data accuracy
Why Join Amgen?
- Work with a top global biotechnology company
- Exposure to innovative clinical research and global studies
- Strong focus on quality, compliance, and patient safety
- Competitive compensation and long-term career growth
- Inclusive and equal opportunity workplace
Estimated Salary Range (India)
💰 ₹6,00,000 – ₹10,00,000 per annum (based on experience and internal benchmarks)
How to Apply
Application Link Study Delivery Associate
Application Link Study Delivery Sr Associate
