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Job description
The Send Specialist II is responsible for submission of final SEND Datasets to Sponsors.
Responsibilities and Duties:
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
Position Requirements:
Education and Experience
B.S. degree and/or 2-5 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
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
Performance Requirements:
Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
General
Ability to read, write, speak and understand English
Ability to read, write and understand oral and/or written instructions
Physical Activity
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
Working Conditions
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
Tools, Equipment, & Other Resources Used:
Various software applications sustained by a Windows platform. (Excel Word, PowerPoint, etc.)
Data Entry/SEND export software
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*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.
At Inotiv, our work helps advance the development of new medicines and therapies that can improve people's lives. As a leading global contract research organization (CRO), we partner with researchers to tackle complex scientific challenges, drive innovation, and help build a healthier, safer world. Bringing together scientists, researchers, technical experts, and business professionals, we provide the expertise and collaboration needed to move research forward. Our people make this work possible, and we value the knowledge, ideas, and contributions each person brings to the team. Whether you are starting your career or bringing years of experience, Inotiv offers opportunities to learn, grow, and play a meaningful role in advancing treatments for patients around the world.
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
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Worksite address
evansville, IN, 47725, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.