Senior Data Management Specialist

3 weeks ago


Bedminster, New Jersey, United States INTRA-CELLULAR THERAPIES INC Full time
About the Role

This is a Senior Data Management Specialist position at Intra-Cellular Therapies Inc., where you will oversee and provide guidance on data management services for clinical studies.

Key Responsibilities:

  • Provide technical guidance to cross-functional study teams.
  • Perform and closely monitor/manage user acceptance testing and technical reviews.
  • Provide expertise regarding the interpretation of regulations and policies as they relate to critical compliance areas for clinical trials.
  • Review and suggest improvements to operating procedures and policies.
  • Contribute and drive ongoing process improvement initiatives.
  • Ensure standard procedures for study and data management are in compliance with industry practices and company policies and procedures.

Requirements:

  • Bachelor, Master, or PhD in quantitative or health-related fields.
  • Minimum of 7 years of experience in Data Management in pharmaceutical clinical trials.
  • Strong interpersonal skills and working knowledge of FDA/EU and ICH-GCP regulations and guidelines.
  • Capable of collaboratively engaging with external 3rd parties.

What We Offer:

  • Base Salary Range $130,000 - $165,000.
  • Opportunities for professional growth and development.

About Us:

Intra-Cellular Therapies Inc. is an Equal Employment Opportunity/Affirmative Action Employer.


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