Study Delivery Associate

Amgen · Hyderabad

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Job Description

Role Name: Study Delivery Associate

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

 ABOUT THE ROLE

Role Description:

The Study Delivery Associate provides essential administrative and operational support to clinical trial management activities. This role supports the Study Delivery Team in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination, document and system management.

The Study Delivery Associate may also support specialized activities to promote expertise, quality, and consistency across studies. Key responsibilities include maintaining accurate and timely data within clinical systems (e.g., CTMS) and supporting study training and related operational requirements.

Roles & Responsibilities:

Study Coordination​

• Support the setup and maintenance of study-level trackers, dashboards and timelines. ​
• Communicate study progress, timelines and deliverables to the Study Delivery Manager.​
• Assist with tracking and following up on study actions, including risk mitigation actions.​
• Assist with the preparation and record keeping of risk & quality reviews.​
• Ensure completion of study team training and inspection readiness activities to maintain compliance with regulatory requirements. ​
• Assist with trial-related events, global site communications, and logistics for investigator meetings​
• Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness.​
• Support vendor relationships and site engagement strategies.​
• Manage shipment, reconciliation and analysis of biological samples.​
• Coordinate investigational product logistics, ensuring compliance with reconciliation processes.

Data & Systems Management​

• Maintain clinical trial systems (e.g., CTMS, study training), ensuring timely and accurate data entry.​
• Support system access requests and access management.

Document Preparation​

• Assist with preparing, reviewing and maintaining study documentation, including regulatory submissions, monitoring plans and study guides. ​
• Support TMF filing.​

Process Improvement & Knowledge Sharing​

• Contribute to process improvement and share knowledge & share knowledge and experience.

Basic Qualifications and Experience:

• Bachelor’s degree OR
• Associate’s degree and 4 years of clinical execution experience OR
• High school diploma / GED and 6 years of clinical execution experience 

Preferred Qualifications and Experience:

2 years' work experience in life sciences or medically related field, including 1 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company Experience working on global clinical trials

Competencies:

• 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
• 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.
• 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
• Cultural sensitivity and collaboration across global teams.
• Ability to recognize, highlight and resolve issues.  Demonstrates curiosity and willingness to take on new tasks.

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