Senior Director of Data Management
Virtual Vocations Inc, New York, NY, United States
A company is looking for a Senior Director of Data Management.
Key Responsibilities:
Provide strategic leadership and oversight of data management activities across clinical studies and programs Oversee the design, review, and approval of case report forms (CRFs) and related data collection tools Ensure compliance with GCP, ICH guidelines, CDISC standards, and applicable regulatory requirements
Required Qualifications:
Bachelor's degree is required with 12-15+ years of data management experience in the pharmaceutical, biotech, or CRO industry Demonstrated leadership experience overseeing studies and/or managing CRO/vendor partnerships Extensive hands-on knowledge and experience in data management activities, CRF and EDC design, review, and validation Working knowledge of CDISC standards (SDTM) and experience supporting data transformation for regulatory submissions Deep understanding of GCP, ICH, and global regulatory requirements
Provide strategic leadership and oversight of data management activities across clinical studies and programs Oversee the design, review, and approval of case report forms (CRFs) and related data collection tools Ensure compliance with GCP, ICH guidelines, CDISC standards, and applicable regulatory requirements
Required Qualifications:
Bachelor's degree is required with 12-15+ years of data management experience in the pharmaceutical, biotech, or CRO industry Demonstrated leadership experience overseeing studies and/or managing CRO/vendor partnerships Extensive hands-on knowledge and experience in data management activities, CRF and EDC design, review, and validation Working knowledge of CDISC standards (SDTM) and experience supporting data transformation for regulatory submissions Deep understanding of GCP, ICH, and global regulatory requirements