Send Specialist I

Inotiv•Evansville, IN

3d•$60,000 - $90,000•Remote

About The Position

The Send Specialist I is responsible for submitting final SEND datasets to sponsors. The role generates and reviews SEND datasets, prepares nSDRG and Define files for deliverables, and works with third-party vendors when needed. It also supports internal SEND initiatives and implementation or upgrades, maintains current knowledge of industry practices, and may assist with training new hires once established. The specialist collaborates with Study Directors, Principal Investigators, their representatives, and cross-functional teams to meet SEND milestones and timelines. Other assigned duties may include supporting the Document Specialist team with protocol or report QC and providing statistical analysis support.

Requirements

B.S. degree and/or 1–3 years of industry experience.
Attention to detail and experience reviewing and quality-checking nonclinical study data and reports.
Ability to work independently and achieve objectives in a timely manner.
Strong interpersonal, organizational, and communication skills.
Experienced knowledge of CDISC and the SEND Implementation Guide (SENDIG).
Knowledge of FDA GLPs and the design and conduct of nonclinical studies.
Ability to read, write, speak, and understand English, and to read, write, and understand oral and/or written instructions.
Ability to perform manual dexterity tasks using a calculator and/or computer.
Physical activity may include frequent walking, extended periods of sitting, carrying, standing, lifting at least 20 pounds, reaching while standing, gripping and twisting hand movements, finger control, and other repetitive motions.
A Mantoux TB test with a negative result may be required.
Ability to wear latex or nitrile gloves, a dust mask and/or respirator, and safety glasses as required.
May be exposed to animal dander and/or materials associated with animal husbandry.

Nice To Haves

Working knowledge of statistical analysis programs such as SAS and Prism is desirable.

Responsibilities

Generate SEND datasets using Inotiv’s electronic data collection system.
Ensure generated work complies with the most current regulations.
Review and quality-check SEND datasets and/or manipulated domains for accuracy against study reports and protocols.
Create nSDRG and Define files for all SEND deliverables.
Work with third-party vendors as needed to generate SEND packages.
Participate in internal SEND initiatives and the continued implementation or upgrade of SEND and related activities.
Participate in training, including webinars and conferences, to maintain compliance with current industry practices and guidelines and stay current with industry trends.
Once established, assist with training new hires on SEND QC and generation processes.
Interact and collaborate effectively with Study Directors, Principal Investigators, representatives, and cross-functional teams.
Meet SEND-related milestones and timelines consistently.
Perform other assigned duties, which may include supporting the Document Specialist team with protocol QC and report QC, and statistical analysis.