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Manager, CSAR - Study Design and Programming

Manager, CSAR - Study Design and Programming

ConfidentialHyderabad / Secunderabad, Telangana
26 days ago
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)
  • Skills Required

    Data Management, Project Managment, Risk Management

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