The Manager, CSAR

3 weeks 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 writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen.
- 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).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

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
- Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors.
- 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 field
- 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 field with 6 to 8 years of experience.
- Masters degree and 4 to 6 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)

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