Send Specialist II

Summary

Inotiv is a global contract research organization that partners with researchers to advance the development of new medicines and therapies. The Send Specialist II is responsible for generating, reviewing, quality-controlling, and submitting final SEND datasets and related deliverables to sponsors while ensuring regulatory compliance and meeting project timelines.

Responsibilities

• 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
• May perform other duties as assigned such as providing support to Document Specialist team (protocol QC, report QC, etc.) and statistical analysis

Skills

• B.S. degree and/or 2-5 years of industry experience
• 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
• Experienced knowledge of CDISC and SEND Implementation Guide (SENDIG)
• Knowledge of FDA GLPs and the design and conduct of nonclinical studies
• Ability to read, write, speak and understand English
• Ability to read, write and understand oral and/or written instructions
• Manual dexterity to use a calculator and/or computer
• Frequent walking, sitting for extended periods of time, carrying, standing, heavy lifting (min. 20 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions
• Able to wear latex or nitrile gloves, dust mask and/or respirator, and safety glasses as required
• Working knowledge of statistical analysis programs (SAS, Prism, etc.) desirable

Qualifications

Must Haves

• B.S. degree and/or 2-5 years of industry experience
• 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
• Experienced knowledge of CDISC and SEND Implementation Guide (SENDIG)
• Knowledge of FDA GLPs and the design and conduct of nonclinical studies
• Ability to read, write, speak and understand English
• Ability to read, write and understand oral and/or written instructions
• Manual dexterity to use a calculator and/or computer
• Frequent walking, sitting for extended periods of time, carrying, standing, heavy lifting (min. 20 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions
• Able to wear latex or nitrile gloves, dust mask and/or respirator, and safety glasses as required

Nice to Haves

• Working knowledge of statistical analysis programs (SAS, Prism, etc.) desirable

Benefits

• Remote work arrangement
• Health and dental coverage
• Short- and long-term disability coverage
• Paid time off
• Paid parental leave
• 401K