Infosys is seeking Principal Consultant with Clinical data management experience. As a Principal 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 business requirement and process artifacts and assist with the overall deployment. 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.

Required Qualifications:

• Candidate must be located within commuting distance of Bridgewater, NJ or Hartford, CT be willing to relocate to the area. This position may require travel in the US
• Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
• Minimum 11 Years of Information Technology experience.
• At least 6 Years' experience in End-end Clinical trial management process and related applications.
• Experience in Clinical data management applications such as oc/rdc/tms.
• Experience on clinical reporting (internal, FDA) during study start to closeout phases.
• Knowledge of Clinical Data Management processes with knowledge of Clinical Data Warehouse
• Experience in Computer systems Validation activities
• 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.
• Experience in the full System Development Life Cycle (SDLC) on a variety of technologies and platforms preferably in pharma IT space.
• A basic knowledge writing custom queries in SQL or PL/SQL is needed for data extraction and validation.
• Candidates authorized to work for any employer in the [United States/Canada] without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time.

Preferred Qualifications:

• A basic knowledge writing custom queries in SQL or PL/SQL is needed for data extraction and validation.
• Experience with project management .
• Experience and desire to work in a management consulting environment that requires regular travel .
• Planning and Co-ordination skills .
• Good Communication and Analytical skills.
• Experience with Agile Scrum Methodology

The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone, email or face to face.