Study Delivery Senior Associate (SDSA)
Role Name: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,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown today.
The Study Delivery Senior Associate provides essential globalstudy managementsupport to clinical study teams, ensuringtimely, high-quality, and compliant study execution.TheypartnerwithStudy Managerstodeliverstart-up and conduct activities, own specific study tasksandsupportriskmonitoringand issue management,escalatingearly warning signals with proposed solutions to relevant stakeholders.
The Study Delivery Senior Associatewill beassigned to individual study teamsandspecializein processessupporting many study teamsthroughout their study lifecycle, enablingopportunities to gainvariedexperience instudy management.
Roles & Responsibilities:
Study Planning & Coordination
Leadthe 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.
Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completiontorequired standards.
Study Execution & Oversight
Use study dashboards and reports tomonitorglobal enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.
PreferredQualifications and Experience:
3years’work experience in life sciences or medically related field, including 1yearof biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Expertisein 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 tomaintainaccurateandtimelydata entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
Experience executing risk-based site monitoring,Audit and InspectionsCorrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness
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 toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestaccommodation.
