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Study Delivery Sr Associate

3 weeks ago

Hyderabad, Telangana, India Amgen Full time
Career CategoryResearchJob Description

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, 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 study management support to clinical study teams, ensuring timely, high-quality, and compliant study execution. They partner with Study Managers to deliver start-up and conduct activities, own specific study tasks and support risk monitoring and issue management, escalating early warning signals with proposed solutions to relevant stakeholders.

The Study Delivery Senior Associate will be assigned to individual study teams and specialize in processes supporting many study teams throughout their study lifecycle, enabling opportunities to gain varied experience in study management.

Roles & Responsibilities:

Study Planning & Coordination

  • Lead 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.
  • Manage Study Training system activities and oversight

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 escalate risks effectively to support swift, informed decisions

Site & Vendor Engagement

  • Lead vendors and supplier set-up 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 Audit/Inspections including 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:

  • Strong collaborative and effective communication skills within a team environment.
  • 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 and suppliers
  • Experience executing risk-based site monitoring, Audit and Inspections 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 accommodation.

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