Manager, CSAR – Custom function Programming

Biopharma Careers; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Amgen is seeking a Study Designer and Edit Check Programmer to join our CSAR/GDO operations in Hyderabad. The role collaborates with Clinical Study Teams and cross-functional staff to build, test, and maintain studies in the clinical database, ensuring adherence to Amgen standards and regulatory requirements.

The successful candidate will bring strong experience in EDC platforms (Rave, Veeva), programming for edit checks, and translating data into actionable insights while supporting quality

Qualifications

• Good Clinical Practice and regulatory awareness.
• Experience with data management and clinical trial databases.
• Proficiency in edit check development and programming.
• Ability to work with cross-functional teams and global partners.
• Knowledge of SDLC, project planning and quality management.

Responsibilities

• Support of clinical trial platform technologies.
• Act as data scientist to provide analytical insights.
• Coordinate programming support for Clinical Study Teams.
• Ensure proper use of EDC per procedures.
• Serve as technical contact for system deliverables.
• Propose and implement system enhancements and new tools.
• Provide input on new technologies and processes.
• Develop and implement policies and SOPs.
• Ensure documentation aligns with regulatory standards.
• Assist in audits and responses.

Skills

Good Clinical Practice

Performance management

Data management

Clinical trial databases

Edit check programming

Programming languages

Systems development lifecycle

Project planning

Cross-functional collaboration

Quality & risk analysis

Regulatory filings

Process improvement

Education

Bachelor's degree in life science / computer science / related discipline

Advanced degree in life science / computer science / math / statistics / business

Tools

Rave EDC

Veeva EDC

Job description

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving Patients

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.

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).

• 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 (CRO’s, 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)