Study Delivery Sr Associate

Career Category

Operations

Job Description

Role Name:   Study Delivery Senior Associate

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 ,   escalat ing   early warning signals with proposed solutions to relevant stakeholders.

The Study Delivery Senior Associate   will be   assigned to individual study teams   and   specialize   in process es   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 collaborati ve   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.

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