[Hiring] Send Specialist II @Inotiv

Role Description

The Send Specialist II is responsible for submission of final SEND Datasets to Sponsors.

• 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.

Qualifications

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

Requirements

• 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.
• Mantoux TB test with negative result may be required.
• Able to wear latex or nitrile gloves, dust mask and/or respirator, and safety glasses as required.
• May be exposed to animal dander and/or material associated with animal husbandry.
• The noise level is usually moderate.

Benefits

• Health and dental coverage.
• Short- and long-term disability.
• Paid time off.
• Paid parental leave.
• 401K.
• Salary will be commensurate with experience and responsibilities.