Clinical Data Management Expert

4 days ago


Brockton, Massachusetts, United States Infosys Full time
About the Role

Infosys is seeking a highly skilled Clinical Data Management Expert to join our team. As a key player in our consulting team, you will play a crucial role in helping us discover and define problem statements, evaluate solution options, and make recommendations. You will create business requirements and process artifacts, and assist with the overall deployment of our solutions.

Key Responsibilities:

  • Develop and maintain a deep understanding of clinical data management processes and related applications.
  • Collaborate with cross-functional teams to design and implement clinical data management solutions.
  • Conduct business requirement analysis and use case modeling from a business analysis/consulting standpoint.
  • Provide expertise in clinical data management applications such as OC/ RDC/TMS.
  • Ensure compliance with Good Clinical Practices, Good Documentation practices, and Clinical Trial Quality & Compliance.
  • Travel regularly to client sites to provide consulting services.

Requirements:

  • Bachelor's degree or foreign equivalent required from an accredited institution.
  • At least 2 years' experience in IT, with a focus on clinical data management.
  • End-to-end clinical trial management process experience and related applications.
  • Knowledge of clinical data warehouse and clinical reporting (internal, FDA) during study start to closeout phases.
  • Experience in computer systems validation activities.
  • Familiarity with Good Clinical Practices, Good Documentation practices, Clinical Trial Quality & Compliance.

Preferred Qualifications:

  • Experience working in a management consulting environment that requires regular travel.
  • Planning and coordination skills.
  • Good communication and analytical skills.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


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