- We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting.
- The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology.
- We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).
Responsibilities include, but are not limited to,
the following:
- Support of clinical trial platform technologies.
- Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.
- Coordinating and providing programming support to Clinical Study Teams.
- Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards.
- Acting as a technical point of contact for systems deliverables on defined programs.
- Identify, recommend or implement system enhancements, current tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment.
- Providing technical and business process input / expertise on new and emerging technologies.
- Develop, review and implement policies, SOPs and associated documents.
- Ensure documentation supports CSAR operational or technical activities i