Study Delivery Sr Associate

Career Category Business Development Job 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 ,   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.  

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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