Posted: 2 weeks ago
Posted: 2 weeks ago
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Job Description
Role Name:Study Delivery Senior Associate
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples 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 beyondwhatsknown today.
ABOUT THE ROLE
Role Description:
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 studytasksandsupportriskmonitoringand 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.
- Coordinatelogisticsfor investigator meetings, trial events, and site communications.
- 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.
- Lead delivery of assigned risk and quality management activities
- Track and report study progress, coordinating with Studyteamand vendors to resolve operational issues andmaintaincompliance.
- Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.
- Manage Study Trainingsystem activitiesand oversight
Stakeholder Engagement Team Collaboration
- Build andmaintaineffective relationships with internal study team members,vendorsand 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
- Leadvendorsand supplierset-upto ensure quality, speed, and consistency in deliverables.
Data Systems Management
- Maintain andmonitorclinical trial systems (e.g., CTMS), ensuringaccurateandtimelydata entry and reporting.
- Support data collection oversight, including query resolution and reconciliation activities.
- Manage trial documentation (e.g., TMF) to ensureinspectionreadiness.
Process Improvement Knowledge Sharing
- Contribute to best practice development, knowledge-sharingand process improvement within the study support community.
- Proactivelyidentifyand highlight opportunities to streamline / automate activities within remit.
- SupportAudit/InspectionsincludingCorrective and Preventive Actions(CAPA)processes and embed lessons learned across studies.
Basic Qualifications and Experience:
- Masters degree OR
- Bachelors degree and 2 years of clinical execution experience OR
- Associates degree and 6 years of clinical execution experience OR
- High school diploma / GED and 8 years of clinical execution experience
PreferredQualifications and Experience:
- 3yearswork 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
- Experience working on global clinical trials
Competencies:
- Strong collaborativeand effectivecommunication skillswithina 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 vendorsand suppliers
- 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
- 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 areversion-controlled and inspection-ready.
Skills
Drug DevelopmentDataEtmfResearchManagementCapaClinicalBiologyOperationsMaintenanceSupply PlanningDeliveryIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Amn Technologies Ltd is a computer software company based out of 145-157 St John Street, London, United Kingdom. Industries: Software Development. It's a private unlisted company and is classified as'company limited by shares'. Company's authorized capital stands at Rs 60.0 lakhs. AMN TECHNOLOGY PRIVATE LIMITED is a private limited Indian company based in Bangalore, India and it was officially incorporated on 29/12/2014.
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