Study Designer and Edit Check Programmer (CSAR)

About the role

Amgen is looking for a Study Designer and Edit Check Programmer to report directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The role helps build and program studies in the clinical trial database in line with Amgen's standards, procedures and best practices, and works closely with CSAR Operations and cross-functional teams on electronic data capture. It suits a strong leader who can influence stakeholders and contributes to study-specific and general CSAR/GDO projects.

Key responsibilities

• Support clinical trial platform technologies and act as a data scientist, bringing awareness of patterns and analytical insights to decision-making.
• Coordinate and provide programming support to Clinical Study Teams, ensuring efficient and consistent use of the EDC system in line with established procedures.
• Act as technical point of contact for systems deliverables on defined programs.
• Identify, recommend or implement system enhancements, new tools or emerging technologies to shorten database development cycles.
• Provide technical and business-process input on new and emerging technologies.
• Develop, review and implement policies, SOPs and associated documents, keeping documentation complete and consistent with regulatory requirements.
• Assist in preparing for and responding to audit findings (internal or external).

Required profile

• Bachelor's degree or equivalent in life sciences, computer science, business administration or a related discipline, with 9 to 12 years of experience.
• Specialist knowledge or experience in life sciences or a medically related field.
• General biopharmaceutical clinical research experience (clinical trials at a biotech, pharmaceutical or CRO company).
• Preferred: advanced degree; broad data management and programming experience in pharma/biotech; project management experience; oversight of outside vendors (CROs, central labs, imaging vendors, IRT vendors).

Required skills

• Knowledge of Good Clinical Practice, drug development and clinical trials processes, and data management processes.
• Clinical trial databases and applications, edit check development and custom function programming.
• Programming languages, systems development lifecycle, project planning and management.
• Operational experience with clinical database management systems such as Rave EDC and Veeva EDC.