15h Left) Manager, CSAR

1 day ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

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
- Works collaboratively with Clinical Data Management to meet study deliverables and timelines
- Acting as a technical point of contact for systems deliverables on defined programs
- Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios.
- Providing technical and business process input / expertise on new and emerging technologies
- Develop, review and implement policies, SOPs and associated documents
- 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
- Programming of clinical trial databases and applications
- Proficient in SAS programming and Spotfire data visualization software
- Systems development lifecycle
- Programming Languages
- 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 with 9-13 years of experience

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

- Bachelor's degree or equivalent in life science, computer science, business administration or related discipline
- 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)

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