Study Delivery Sr Associate

Amgen Inc. (IR); Hyderabad; On-site; INR 900,000 - 1,200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Study Delivery Senior Associate in Hyderabad, India. The role focuses on supporting clinical study teams to ensure high-quality and compliant study execution. Ideal candidates will have a relevant degree and experience in clinical research. Responsibilities include managing study tasks, contributing to process improvements, and ensuring inspection readiness. Strong communication skills and proficiency in relevant software are essential for this position.

Qualifications

• 2 years of clinical execution experience or equivalent.
• 3 years in biopharmaceutical clinical research preferred.
• Experience working on global clinical trials.

Responsibilities

• Provide global study management support to clinical teams.
• Ensure high-quality and compliant study execution.
• Contribute to process improvement and knowledge sharing.
• Oversee vendor/supplier activities and regulatory submissions.
• Maintain accurate investigator documentation and version-controlled essential documents.

Skills

Strong collaborative and effective communication skills

Proficiency in MS Word

Proficiency in Excel

Proficiency in PowerPoint

Knowledge of CTMS, eTMF, EDC

Experience in clinical trial data management

Excellent problem-solving skills

MS Excel

MS PowerPoint

Education

Bachelor's degree in a relevant field

Associate's degree

High school diploma / GED

Tools

CTMS software

eTMF systems

EDC software

Microsoft Office tools

Job description

**Role Name:**Study Delivery Senior Associate ABOUT THE ROLE Role 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 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.Roles & Responsibilities: **Process Improvement & Knowledge Sharing** Contribute to best practice development, knowledge-sharing and process improvement within the study support community.Basic Qualifications and Experience: 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 Preferred Qualifications and Experience:3 years’year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company work experience in life sciences or medically related field, including 1 Experience working on global clinical trials Competencies:Strong collaborative and effective communication skills within a team environment. 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 suppliersExperience executing risk-based site monitoring, Audit and Inspections Corrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readinessAbility to recognize, highlight and resolve issues. Demonstrates curiosity and willingness to take on new tasks. 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.