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Key skills for this role
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).
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
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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).
Good Clinical Practice
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Drug development and clinical trials processes
Data management processes
Clinical trial databases and applications
Edit check development and Custom function programing
Programming Languages
Systems development lifecycle
Project planning and management
Collaborating with global cross-functional teams (team/matrix environment)
Quality management and Risk Analysis
Regulatory filings and inspections
Process improvement methodologies
Developing innovative medicines to fight serious diseases.
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Senior · 9+ years experience
Onsite
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