Study Delivery Sr Associate

Amgen; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

A leading biotechnology company seeks a Study Delivery Senior Associate to provide operational support for clinical studies. This role includes managing study execution and logistics, ensuring compliance, and building relationships with internal teams and vendors. Candidates should have a Master's degree or equivalent experience in clinical execution, along with strong skills in documentation and data management. The successful candidate will contribute to optimizing study processes and help achieve enrollment targets.

Qualifications

• Master’s degree or equivalent experience.
• 2+ years of clinical execution experience for Bachelor's degree holders.
• 6+ years for Associate’s degree or 8+ years for High school diploma holders.

Responsibilities

• Provide operational support to clinical study teams.
• Coordinate study planning and execution logistics.
• Manage assigned start-up activities and ensure compliance.

Skills

Documentation accuracy

Clinical trial processes

MS Word, Excel, PowerPoint

Vendor oversight

Cultural sensitivity

Risk mitigation

Education

Master’s degree

Bachelor’s degree with 2 years clinical execution experience

Associate’s degree with 6 years clinical execution experience

High school diploma/GED with 8 years clinical execution experience

Tools

CTMS

eTMF

EDC

Microsoft Office Suite

Job description

Study Delivery Senior Associate

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.

Role Description

The Study Delivery Senior Associate provides essential global operational support to clinical study teams, ensuring timely, high‑quality, and compliant study execution. They complete assignments by the Study Managers and Leads, own specific study tasks, support monitoring for risks or issues, and elevate early warning signals with proposed solutions to relevant stakeholders.

Roles & Responsibilities

Study Planning & Coordination

• Support and sometimes own 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.

Study Execution & Oversight

• 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.

Stakeholder Engagement & Team Collaboration

• 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 elevate risks effectively to support swift, informed decisions.

Site & Vendor Engagement

• Coordinate with vendors and suppliers to ensure quality, speed, and consistency in deliverables.

Data & Systems Management

• 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.

Process Improvement & Knowledge Sharing

• Contribute to best practice development, knowledge‑sharing and process improvement within the study support community.
• Proactively identify and highlight opportunities to streamline and automate activities within remit.
• Support Corrective 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

Preferred Qualifications and 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

Competencies

• 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
• Experience executing risk‑based site monitoring, 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.

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 to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.