Study Delivery Associate

Role & Responsibilities

Study Planning & Coordination
Develop and maintain study trackers, dashboards, timelines and operational tools
Coordinate logistics for investigator meetings, site communications and trial-related events
Support study start-up 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
Serve 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

Qualification

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 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

Skills
Strong understanding of clinical trial operations and compliance
TMF filing and regulatory documentation knowledge
Excellent coordination, communication and problem-solving skills
High attention to detail and data accuracy
Ability to work in global cross-functional teams

About the Company
Amgen is a global biotechnology leader focused on developing innovative medicines that improve the lives of patients worldwide. With a strong commitment to science, quality, and patient safety, Amgen delivers breakthrough therapies across multiple therapeutic areas and supports world-class global clinical research operations.