Amgen
Website:
amgen.com
Job details:
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 Data Acquisition Analyst supports external and non-CRF clinical data acquisition activities, including data integrations, reconciliation, vendor data tracking, and study readiness support. This role assists with external data workflows involving labs, imaging, eCOA, IRT, wearable devices, and other vendor data sources while ensuring compliance with established standards and procedures.
This role collaborates with Database Design teams, Clinical Data Management, vendors, and study teams to support efficient data integration workflows and reliable downstream data utilization.
Roles & Responsibilities:
- Lead and support external data acquisition activities, ensuring efficient integration workflows and alignment with study requirements.
- Drive data interoperability and coordinate across the external data ecosystem.
- Execute routine processing and tracking of external and non-CRF datasets including labs, imaging, eCOA, IRT, and wearable device data.
- Assist with preparation and maintenance of vendor data transfer specifications and reconciliation documentation.
- Monitor incoming vendor files for completeness, formatting, and delivery issues.
- Execute assigned reconciliation and data review activities and document findings accurately.
- Track external data issues and escalate discrepancies or delays appropriately.
- Maintain study documentation, quality tracking records, and audit-ready records associated with vendor data integrations.
- Coordinate with Database Design and Clinical Data Management teams to support data integration activities.
- Participate in study team meetings and provide status updates on assigned activities.
- Follow established SOPs, work instructions, and standards for vendor data management.
- Support execution and coordination of external clinical data integration activities.
Accountabilities:
- Support timely acquisition, tracking, and integration of non-CRF and external datasets.
- Assist with vendor data transfer documentation, reconciliation activities, and defect tracking.
- Contribute to study readiness activities by supporting external data management and maintaining accurate documentation.
- Maintain compliance with SOPs, data standards, and regulatory requirements related to clinical data acquisition.
Basic Qualifications and Experience:
- Bachelor’s degree in life sciences, computer science, health sciences, or related discipline and 3 years of clinical research, data management, or vendor management experience in EDC systems such as Rave, Veeva, or similar platforms; OR
- Master’s degree in life sciences, computer science, health sciences, or related discipline and 2 years of clinical research, data management, or vendor management experience in EDC systems such as Rave, Veeva, or similar platforms.
- Experience in clinical data management, vendor data integration, or clinical operations.
- Working knowledge of EDC systems and vendor/external clinical data processes.
- Familiarity with clinical trial terminology and study workflows.
Preferred Experience:
- 3–5 years of experience in clinical data management, vendor data integration, or clinical operations.
- Experience working within regulated or quality-focused environments.
- Proficiency with Microsoft Office tools.
- Exposure to external clinical data processes and reconciliation activities.
Functional Competencies:
- Foundational understanding of clinical trial operations and external data management.
- Basic knowledge of EDC systems, CTMS, and eTMF environments.
- Strong understanding of external data structures and vendor data transfer workflows.
- Knowledge of reconciliation concepts and scalable data integration practices.
- Strong attention to detail and documentation accuracy.
- Ability to follow established procedures and standards consistently.
- Effective written and verbal communication skills.
- Ability to identify and escalate risks appropriately.
- Strong organizational and time management skills.
- Collaborative mindset and willingness to learn new systems and processes.
- Commitment to quality, compliance, and continuous improvement.
- Demonstrates learning agility and works effectively within established processes.
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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