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Study Delivery Sr Associate

Amgen -
Hyderabad, Telangana

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Job details

Qualifications

Microsoft Powerpoint
Microsoft Word
Clinical research
Filing
Process improvement
Research
Microsoft Office
12th Pass
Bachelor's degree
Data management
Data entry
Clinical trials

Full job description

India - Hyderabad

JOB ID: R-238189 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 06, 2026 CATEGORY: Clinical

Job Description:

Study Delivery Associate

Role Name:Study Delivery Sr Associate

Role GCF: 4

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown 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 DeliveryTeam in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination,documentand system management.

TheStudy DeliveryAssociatemayalsosupportspecializedactivities to promoteexpertise, quality, and consistency across studies. Key responsibilities includemaintainingaccurateandtimelydata 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,dashboardsand timelines.

Communicate study progress,timelinesand deliverables to the Study Delivery Manager.

Assistwith tracking and following up on study actions, including risk mitigation actions.

Assistwith the preparation and record keeping of risk & quality reviews.

Ensure completion of study team training andinspectionreadiness activities tomaintaincompliance with regulatory requirements.

Assistwith trial-related events, global site communications, andlogisticsfor 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,reconciliationand analysis of biological samples.

Coordinate investigational productlogistics, ensuring compliance with reconciliation processes.

Data & Systems Management

Maintain clinical trial systems (e.g., CTMS, study training), ensuringtimelyandaccuratedata entry.

Support system access requests and access management.

Document Preparation

Assistwith preparing,reviewingandmaintainingstudy documentation, including regulatory submissions, monitoringplansand study guides.

Support TMF filing.

Process Improvement & Knowledge Sharing

Contribute to process improvement and share knowledge& shareknowledge 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

PreferredQualifications 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:

Expertisein 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 withtracking and filingof 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,highlightand resolve issues. Demonstrates curiosity and willingness to take on new tasks.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.

Apply Now

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