Manager, CSAR – Custom Function Programming

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, new 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 is in a complete manner and consistent with regulatory and the established processes.
• Assist in preparing for and responding to audit findings (internal or external).

Knowledge

• 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

Preferred Qualifications

• Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline
• Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
• General project management and planning experience
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.)

Basic Qualifications

• Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experience
• Specialist knowledge / experience in life sciences or a medically related field
• General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)