Manager, CSAR

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

We are seeking a talented individual to join us as a Study Designer and Edit Check Programmer within the Clinical Systems and Analytical Reporting (CSAR) team. This role is a crucial blend of technical expertise and leadership, where you'll build and program studies in our clinical trial database while ensuring compliance with Amgen's standards and procedures. You will act as a strong leader, influencing stakeholders and collaborating with cross-functional teams to deliver high-quality, seamless deliverables related to electronic data capture technology.

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.

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