ITI, Inc., a wholly-owned subsidiary of Intra-Cellular Therapies, Inc. in Bedminster, NJ seeks an Associate Director, Data Management to provide expertise regarding the interpretation of regulations & policies as they relate to critical compliance areas for clinical trials. Position allows for 100% remote work from anywhere within the United States.
Job Requirements:
- Bach degree or foreign equiv in Information Studies, Data Science, Mathematical Science, or a closely related quantitative field
- 5 years of experience in data management in pharmaceutical clinical trials or similar
- 5 years of experience with FDA/EU & ICH-GCP regulations & guidelines
- Experience engaging with external 3rd parties such as CROs or external consultants
- Experience in all phases of drug development
- Experience utilizing computerized systems
- Ability to meet business objectives & prioritize demands across multiple projects
- Ensuring standard procedures for study and data management are in compliance with industry practices and company policies and procedures
Required Skills:
- Data Management
- FDA Regulations Knowledge
- Clinical Trials
- Drug Development
- Pharmaceutical Experience
Application Instructions:
Please send resume to ITI, Inc., a wholly-owned subsidiary of Intra-Cellular Therapies, Inc., ATTN: Hannah Ameen, hameen@itci-inc.com or 135 US 202/206, Suite 6, Bedminster, NJ 07921. No calls. EEO/AA employer.
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