Study Delivery Sr Associate

Amgen; Hyderabad; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading biotechnology company seeks a Study Delivery Senior Associate in Hyderabad, India. The role involves providing essential operational support to clinical study teams, ensuring compliance and high-quality study execution. Candidates should possess strong skills in clinical trial processes, MS Office, and relevant software tools. Education requirements include a master's degree or equivalent experience. The company offers a full-time position in a dynamic research environment.

Qualifications

• Master’s degree or equivalent experience in related field.
• 2+ years of clinical execution experience preferred.
• Strong understanding of clinical trial execution principles.

Responsibilities

• Provide operational support to clinical study teams.
• Manage logistics for investigator meetings and trial events.
• Track and report study progress and resolve operational issues.

Skills

Expertise in clinical trial processes

Strong skills in MS Word, Excel, and PowerPoint

Cultural sensitivity and collaboration skills

Education

Master’s degree

Bachelor’s degree and 2 years of clinical execution experience

High school diploma / GED and 8 years of clinical execution experience

Tools

CTMS

eTMF

EDC

Job description

6 days ago Be among the first 25 applicants

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

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 escalates 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 / 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 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

• 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.

Seniority Level

Not Applicable

Employment Type

Full‑time

Job Function

Research

Industries

Biotechnology Research and Pharmaceutical Manufacturing