Send Specialist

Consider joining our team- Inotiv Evansville.  

 Inotiv, Inc., is a pharmaceutical development company providing contract research services and monitoring instruments to emerging pharmaceutical companies and the world's leading drug development companies and medical research organizations. The Company focuses on developing innovative services supporting its clients’ discovery and development objectives for improved decision-making and accelerated goal attainment. The Company’s products focus on increasing efficiency, improving data, and reducing the cost of taking new drugs to market.

The responsibilities of a SEND Specialist include:

• Generate SEND datasets utilizing Inotiv’s electronic data collection system 
• Ensure that the work being generated is compliant with the most current regulations
• Review/QC of SEND datasets and/or individual manipulated domains to ensure accuracy against the study report and study protocol
• Create nSDRG and Define file (s) for all SEND deliverables
• Work with 3rd party vendors (as needed) in generation of SEND packages
• Participate in internal SEND initiatives and in the continued implementation/upgrade of SEND and SEND-related activities
• Participate in training (webinars, conferences) to ensure compliance with current practices and guidelines in the industry and keep current with industry trends.
• Once established, assist with training new hires on the SEND QC/generation process
• Effectively interact and collaborate with Study Directors and Principal Investigators, representatives, and cross-functional teams
• Consistently meet SEND-related milestones and timelines

Education and experience

• B.S. degree and/or 2+ years of industry experience

Skills and Abilities

• Attention to detail and experienced with review and QC of nonclinical study data and reports
• Work independently to achieve objectives in a timely manner
• Strong interpersonal, organizational, and communication skills
• Working knowledge of CDISC and SEND Implementation Guide (SENDIG) preferable
• Knowledge of FDA GLPs and the design and conduct of nonclinical studies preferable
• Working knowledge of statistical analysis programs (SAS, Prism, etc.) desirable