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Hiring companyAmgen
Verified today
Study Delivery Senior Associate
Hyderabad, India Full-time On-site
About the role
Study Delivery Senior Associate provides essential global study management support to clinical study teams, ensuring timely, high-quality, and compliant study execution. They partner with Study Managers to deliver start-up and conduct activities, own specific study tasks and support risk monitoring and issue management, escalating early warning signals with proposed solutions to relevant stakeholders. The Study Delivery Senior Associate will be assigned to individual study teams and specialize in processes supporting many study teams throughout their study lifecycle, enabling opportunities to gain varied experience in study management.
What you’ll do
- Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility.
- Coordinate logistics for investigator meetings, trial events, and site communications.
- Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards.
- Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.
- Lead delivery of assigned risk and quality management activities
- Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance.
- Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.
- Manage Study Training system activities and oversight
- Build and maintain effective relationships with internal study team members, vendors and investigator sites
- Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned.
- Identify, prioritize, and elevate risks effectively to support swift, informed decisions
- Lead vendors and supplier set-up to ensure quality, speed, and consistency in deliverables.
- Maintain and monitor clinical trial systems (e.g., CTMS), ensuring accurate and timely data entry and reporting.
- Support data collection oversight, including query resolution and reconciliation activities.
- Manage trial documentation (e.g., TMF) to ensure inspection readiness.
- Contribute to best practice development, knowledge-sharing and process improvement within the study support community.
- Proactively identify and highlight opportunities to streamline / automate activities within remit.
- Support Audit/Inspections including Corrective and Preventive Actions (CAPA) processes and embed lessons learned across studies.
What you’ll bring
- Master’s degree OR
- Bachelor’s degree and 2 years of clinical execution experience OR
- Associate’s degree and 6 years of clinical execution experience OR
- High school diploma / GED and 8 years of clinical execution experience
Nice to have
- 3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience on clinical trials in a biotech, pharmaceutical or CRO company
- Experience working on global clinical trials
Skills
Strong collaborative and effective communication skills within a team environment.Understands importance of accuracy in documentation, data tracking, and compliance checks. Identifies discrepancies and escalates appropriately.Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environmentsStrong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial supportWorking knowledge of CTMS, eTMF, EDC, and Microsoft Office tools. Ability to maintain accurate and timely data entry and manage clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory complianceExperience with overseeing vendors and suppliersExperience executing risk-based site monitoring, Audit and Inspections CAPA implementation, and risk mitigation to resolve operational challenges and ensure inspection readinessCultural sensitivity and collaboration across global teams.Ability to recognize, highlight and resolve issues. Demonstrates curiosity and willingness to take on new tasks.Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principlesExperience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready.