Manager, CSAR

11 hours 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
- 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
- Study build and Edit check development
- 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 with 9+ 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 (CROs, central labs, imaging vendors, IRT vendors, etc.)

Basic Qualifications

- Bachelors 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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