Study Delivery Sr Associate Job at Amgen (Hyderabad)

Job Description

The 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.

Job Responsibility

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 escalate 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

Requirements

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
3 years' work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working on global clinical trials
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 environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Ability to maintain accurate and timely data entry
Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
Experience with overseeing vendors and suppliers
Experience executing risk-based site monitoring, Audit and Inspections Corrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness
Cultural 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 principles
Experience 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

Amgen - All Job Offers

Select Country

Study Delivery Sr Associate

Job Description

Job Responsibility

Requirements

Looking for more opportunities?