CSAR Manager

4 days ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

- 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/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation.
- 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).

Basic Qualifications

- Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9-13 years of experience
- Proven experience in managing teams
- 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).

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
- Proven experience in managing teams
- General project management and planning experience
- Experience in oversight of outside vendors (CRO, central labs, imaging vendors, IRT vendors, etc.)

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 edit check programming
- 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

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