Senior Data Management Specialist

3 days ago

Hyderabad, Telangana, India beBeeDataScientist Full time ₹ 36,00,000 - ₹ 45,00,000

A key member of the clinical study team provides technical and business process input on new and emerging technologies. Supports decision-making by acting as a data scientist and brings awareness to patterns and analytical insights.


Responsibilities:
  • Supports clinical trial platform technologies
  • Coordinates and provides programming support to Clinical Study Teams
  • Ensures efficient and consistent use of EDC system and ensures the use is compliant with established procedures or standards
  • Serves as a technical point of contact for systems deliverables on defined programs
  • Identifies recommends or implements system enhancements new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment
  • Provides technical and business process input / expertise on new and emerging technologies
  • Develops reviews and implements policies SOPs and associated documents
  • Ensures documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and established processes
  • Assists in preparing for and responding to audit findings internal or external

Knowledge and Skills:
  • 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

The ideal candidate will have a strong background in data management and programming with experience in the Pharmaceutical or Biotech arena. They should also possess general project management and planning experience and be familiar with good clinical practice.

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