»  Strategy & Consulting »  Consultant/Sr. Consultant -Clinical Trial and Data Management

3Yrs -13 Yrs       Bangalore / Chennai / Pune / Chandigarh / Gurgaon / Hyderabad / Bhubaneswar     Openings: 5

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The Company

India's marquee global technology & consulting company. They are an international flag-bearer of technical and managerial excellence. With offices around the globe, the company has a comprehensive presence across multiple segments of the technology product and service industries as well as a blue-chip roster of clients for their Consulting engagements. They are a respected career company and a long-term wealth creator.

The Job

As a Consultant, you will be a key player in the consulting team that helps discover and define the problem statement, evaluates the solution options and makes recommendations. You will create detailed design, architecture and process artifacts and implement the deployment plan. You will also support knowledge transfer with the objective of providing value-adding consulting solutions that enable our clients to meet the changing needs of the global landscape.

 Desired Skills & Experience

  • Familiarity with Good Clinical Practices, Good Documentation practices, Clinical Trial Quality & Compliance.
  • Good Knowledge of Study life cycle activities (Study Protocols /study design for IRT and EDC Studies), various study milestones, clinical trial regulatory reports and other metrics reports at study level /site level.
  • Must be able to translate business requirements into well-formed technical and system requirements 
  • Experience with modeling business processes, data flows, and workflow processes depicting relationships between Clinical data entities. 
  • Strong business consulting skills associated with complex IT system implementation spanning over 12-18 months.
  • Strong oral & written communication skills, Business stakeholder management
  • Must have performed business requirement analysis, use case modeling from a business analysis/consulting standpoint. 
  • Experience and desire to work in a management consulting environment that requires regular travel.
Your Profile

We are seeking to identify Masters Degree or Bachelor’s degree or foreign equivalent with Minimum 3+ Years of experience required. 

  • Experience in the full System Development Life Cycle (SDLC) on a variety of technologies and platforms preferably in pharma IT/Life sciences IT space
  • At least 3-15 Years’ experience in one or more of the following skills in Pharma IT/Life sciences domain
    • End-end Clinical trial management process and related applications.
    • Experience in Clinical data management applications such as oc/rdc/tms.
    • Clinical Trial Supply Chain and Inventory management with understanding of Clinical Material Requirement Planning (MRP), Clinical Inventory, Clinical Forecasting, Clinical Packaging, Clinical Labeling, Clinical Distribution, Clinical Depots, Clinical sites, IRT/IVRS and Clinical Trial Management System
    • Experience on clinical reporting (internal, FDA) during study start to closeout phases.
    • Knowledge of Clinical Data Management processes with knowledge of Clinical DataWarehouse
    • Experience in Computer systems Validation activities