Global Data Management Strategist

3 days ago


Bengaluru, Karnataka, India Elanco Full time

Job Summary

The Global Data Management Strategist plays a pivotal role in achieving global clinical data management objectives through systems and processes used during data capture, management, reporting, storage, and archival. This includes electronic data and may involve paper data collection processes and systems.

This position is expected to be highly influential in partnering with product development teams and third parties to develop data management strategies that result in on-target delivery of final databases.

The Global Data Management Strategist will closely collaborate with R&D functions, including clinical development, internal study sites, biostatistics, regulatory affairs, and quality assurance to ensure data integrity, data quality, validation, and compliance.

Key Leadership Responsibilities

  • Proactively search for solutions to achieve overall Elanco R&D deliverables.
  • Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables.
  • Create a positive work environment that is aligned with company objectives.
  • Provide and accept challenge to deliver innovative technical solutions and create an innovative culture.
  • Create an engaging culture with a 'Play to Win' mentality.
  • Identify and utilize methods to deliver individual objectives in a high-quality, timely, and cost-effective manner.
  • Demonstrate high levels of adaptability, flexibility, and learning agility.

Key Technical Responsibilities

  • SUPPORT DEPLOYMENT, VALIDATION, TESTING AND IMPLEMENTATION OF ELECTRONIC DATA CAPTURE SYSTEMS AS PART OF DATA MANAGEMENT STRATEGIES.
  • SUPPORT PREPARATION AND IMPLEMENTATION OF STUDY DATA MANAGEMENT PLANS ACROSS R&D PROJECT TEAMS FROM INITIATION TO COMPLETION.
  • ENSURE ADHERENCE TO CLINICAL DATA COLLECTION POLICIES AND PROCEDURES AND IS EXPECTED TO KEEP ELANCO AT THE FOREFRONT OF STANDARDS FOR THE ANIMAL HEALTH INDUSTRY.
  • CONFIRM VALIDATION AND COMPLIANCE TO ALL REGULATIONS INCLUDING GX P AND GUIDELINES THE GLOBAL DATA MANAGEMENT SYSTEMS AND PROCESS UTILIZED TO COLLECT, MANAGE, REPORT, STORE AND ARCHIVE DATABASES CONTAINING CLINICAL DATA.
  • PART OF THE REGULAR CONNECTS WITH SITE LEAD AND STUDY TEAM SITE STUDY PROGRAM LEADS PERFORM ALL THE DM ACTIVITIES INCLUDING DATA ENTRY VERIFICATION DATA CLEANING ACTIVITIES SUPPORT THE UAT ACTIVITIES ON THE STUDIES ASSIGNED PERFORM THE TMF FILLING ACTIVITIES COMPLETED AT REGULAR INTERVALS PROVIDE THE NECESSARY SUPPORT ON CREATING UPDATING THE STUDY SPECIFIC DOCUMENTS AS NEEDED UPDATE ALL THE DASHBOARDS FOR METRICS GENERATION

Requirements

Mandatory Qualifications:

  • BS or equivalent in IT, statistics, or scientific field related to animal human health or relevant work experience in the animal health industry.
  • 9+ years of experience working in a global network or supporting a global network specifically in animal human health R&D.
  • Knowledge of electronic systems and capabilities and their application in animal human health R&D maintenance validation and data pulls are a plus.


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