Manager, CSAR – Custom Function Programming
Location: Hyderabad, India
Work Location Type: On Site
Job ID: R-210532
Date Posted: April 17, 2025
Category: Engineering
About the Role:
Amgen is seeking a talented individual to join as a Study Designer and Edit Check Programmer, reporting to the Sr. Manager, Clinical Systems and Analytical Reporting. This role is vital in supporting clinical trial database programming while ensuring compliance with Amgen’s standards and best practices. The individual will collaborate closely with CSAR Operations and cross-functional teams to deliver high-quality outputs and activities related to electronic data capture (EDC) technologies, such as Rave EDC and Veeva EDC.
The ideal candidate will demonstrate strong leadership, influence key stakeholders, manage operational work, and bring experience in clinical database management systems.
Roles & Responsibilities:
Provide support for clinical trial platform technologies.
Act as a data scientist to support decision-making by identifying patterns and providing analytical insights.
Coordinate and deliver programming support to Clinical Study Teams.
Ensure efficient and consistent use of the EDC system in compliance with established procedures and standards.
Serve as a technical point of contact for systems deliverables on assigned programs.
Recommend and implement system enhancements, new tools, or emerging technologies to optimize database development cycles.
Provide technical and business process expertise on new and emerging technologies.
Develop, review, and implement policies, SOPs, and associated documentation.
Ensure documentation of CSAR operational or technical activities is complete and compliant with regulatory requirements and established processes.
Assist in audit preparation and responses (internal and external).
Required Knowledge and Skills:
Knowledge of Good Clinical Practice (GCP).
Strong understanding of performance management techniques, problem-solving, and analytical thinking.
Deep knowledge of drug development and clinical trials processes.
Expertise in data management processes and clinical trial databases/applications.
Experience in edit check development and custom function programming.
Proficiency in programming languages relevant to database development.
Understanding of systems development lifecycle.
Strong project planning and management skills.
Ability to collaborate within global cross-functional teams and matrix environments.
Knowledge of quality management and risk analysis.
Experience in regulatory filings and inspections.
Familiarity with process improvement methodologies.
Preferred Qualifications:
Advanced degree or equivalent in life sciences, computer science, math, statistics, business administration, or a related discipline.
Broad knowledge and work experience in data management/programming within the pharmaceutical or biotech industries.
General project management and planning experience.
Experience managing external vendors (CROs, central labs, imaging vendors, IRT vendors, etc.).
Basic Qualifications:
Bachelor’s degree or equivalent in life sciences, computer science, business administration, or a related discipline with 9 to 13 years of relevant experience.
Specialist knowledge or experience in life sciences or a medically related field.
General biopharmaceutical clinical research experience, obtained while working on clinical trials at a biotech, pharmaceutical, or CRO company.
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