Hyderabad Telangana Study delivery sr associate Jobs – 64 Open Jobs Today

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Study Delivery Sr Associate

Amgen -
Hyderabad, Telangana

Apply Now

Job details

13 days ago

Qualifications

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

Full job description

India - Hyderabad

JOB ID: R-240341 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jul. 03, 2026 CATEGORY: Business Development

Job Description:

Study Delivery Senior Associate (SDSA)

Role Name:Study Delivery Senior 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 Senior Associate provides essential globalstudy managementsupport to clinical study teams, ensuringtimely, high-quality, and compliant study execution.TheypartnerwithStudy Managerstodeliverstart-up and conduct activities, own specific study tasksandsupportriskmonitoringand issue management,escalatingearly warning signals with proposed solutions to relevant stakeholders.

The Study Delivery Senior Associatewill beassigned to individual study teamsandspecializein processessupporting many study teamsthroughout their study lifecycle, enablingopportunities to gainvariedexperience instudy management.

Roles & Responsibilities:

Study Planning & Coordination

Leadthe 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.

Coordinatelogisticsfor investigator meetings, trial events, and site communications.

Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completiontorequired standards.

Study Execution & Oversight

Use study dashboards and reports tomonitorglobal 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 Studyteamand vendors to resolve operational issues andmaintaincompliance.

Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.

Manage Study Trainingsystem activitiesand oversight

Stakeholder Engagement & Team Collaboration

Build andmaintaineffective relationships with internal study team members,vendorsand 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

Site & Vendor Engagement

Leadvendorsand supplierset-upto ensure quality, speed, and consistency in deliverables.

Data & Systems Management

Maintain andmonitorclinical trial systems (e.g., CTMS), ensuringaccurateandtimelydata entry and reporting.

Support data collection oversight, including query resolution and reconciliation activities.

Manage trial documentation (e.g., TMF) to ensureinspectionreadiness.

Process Improvement & Knowledge Sharing

Contribute to best practice development, knowledge-sharingand process improvement within the study support community.

Proactivelyidentifyand highlight opportunities to streamline / automate activities within remit.

SupportAudit/InspectionsincludingCorrective and Preventive Actions(CAPA)processes and embed lessons learned across studies.

Basic Qualifications and Experience:

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

PreferredQualifications and Experience:

3years’work experience in life sciences or medically related field, including 1yearof biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

Experience working on global clinical trials

Competencies:

Strong collaborativeand effectivecommunication skillswithina team environment.

Understandsimportanceof accuracy in documentation, data tracking, and compliance checks.Identifiesdiscrepancies and escalates appropriately.

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

Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools. Ability tomaintainaccurateandtimelydata entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance

Experience with overseeing vendorsand suppliers

Experience executing risk-based site monitoring,Audit and InspectionsCorrective 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,highlightand 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 withtracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents areversion-controlled and inspection-ready.

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 requestaccommodation.

Apply Now

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