Manager, CSAR - Custom function Programming

Study Designer and Edit Check Programmer

Roles & Responsibilities

• Study Design & Programming:

  You will build and program studies in the clinical trial database, adhering to Amgen's standards and best practices. A key part of this is the development of

  custom functions and edit checks

  .

• Technical Leadership:

  Serve as a technical point of contact for system deliverables on defined programs. You will provide technical and business process expertise on new and emerging technologies and act as a data scientist to support decision-making through analytical insights.

• Process & Quality Assurance:

  Ensure the efficient and consistent use of

  EDC

  systems in compliance with established procedures. You will also develop, review, and implement policies,

  SOPs

  , and other documentation to ensure all

  CSAR

  activities are consistent with regulatory and established processes.

• Collaboration:

  Partner effectively with other

  CSAR

  Operations and cross-functional staff to ensure seamless deliverables. You'll also assist in preparing for and responding to audit findings.

• Innovation:

  Identify, recommend, or implement system enhancements, new tools, or emerging technologies to decrease database development cycle times and foster a collaborative environment.

Technical Skills & Knowledge

• Strong knowledge of

  Good Clinical Practice

  , drug development, and clinical trial processes.
• Experience in programming and working with

  clinical trial databases and applications

  .
• Expertise in

  edit check development

  and

  custom function programming

  .
• Operational experience with clinical database management systems and allied technologies (e.g.,

  Rave EDC, Veeva EDC

  ).
• Understanding of the systems development lifecycle and programming languages.
• Knowledge of project planning and management, quality management, and risk analysis.
• Broad knowledge or work experience in data management/programming in the pharmaceutical or biotech industry.

Qualifications

• A Bachelor's degree or equivalent in life science, computer science, business administration, or a related discipline.
• An advanced degree is preferred.
• General biopharmaceutical clinical research experience.
• Experience in oversight of outside vendors (

  CROs

  , central labs, etc.) is a plus.

Soft Skills

• Leadership:

  A strong leader with proven experience in influencing stakeholders and mentoring junior team members.

• Problem-Solving:

  Strong analytical and problem-solving skills, with experience in performance management techniques and measures.

• Communication:

  Excellent communication and collaboration skills, with the ability to work effectively with global, cross-functional teams.

• Proactiveness:

  High degree of initiative and self-motivation, with the ability to manage multiple priorities successfully.

• Teamwork:

  Team-oriented, with a focus on achieving team goals.