Amgen
StudyDeliverySrAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Study Delivery Sr Associate at Amgen. Skills: global study management support, clinical study teams, timely, high-quality, and compliant study execution, start-up and conduct activities, risk monitoring, issue management, process improvement, knowledge sharing. Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools. Coordinate logistics for investigator meetings, trial events, and site communications”
What You'll Achieve.
timely, high-quality, and compliant study execution; ensure accuracy and visibility; ensuring completion to required standards; ensure enrollment targets are achieved; ensure quality, speed, and consistency in deliverables; ensuring accurate and timely data entry and reporting; ensure inspection readiness
Industry & Context.
issue management; escalating early warning signals with proposed solutions; proactive action to address deviations and risks; resolve operational issues; Ability to recognize, highlight and resolve issues
What They're Looking For.
Must Have
Master's degree, Bachelor's degree and 2 years of clinical execution experience, Associate's degree and 6 years of clinical execution experience, High school diploma / GED and 8 years of clinical execution experience
Nice to Have
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
What You'll Do.
Lead the development and maintenance of study-level trackers
Coordinate logistics for investigator meetings
and site communications
Manage assigned start-up activities
Use study dashboards and reports to monitor global enrollment
and quality indicators
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
Manage Study Training system activities and oversight
Lead vendors and supplier set-up
Maintain and monitor clinical trial systems
Support data collection oversight
Manage trial documentation
Contribute to best practice development
knowledge-sharing and process improvement
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
How You'll Work.
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; collaboration across global teams
Communication Scope
collaborative and effective communication skills within a team environment; routine study updates
Process & Methodology
study planning, study coordination, study execution, oversight, risk management, quality management, vendor management, stakeholder management, resource planning, continuous improvement
Full Job Description
## **Career Category** Clinical ## ## **Job Description** Job Description **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 assign
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