Data Reviewer
Location : Location
US-IN-West Lafayette
ID
2024-5039
Category
Operations
Type
Full Time - Permanent
Overview
Data Reviewer/Report Writer
Responsibilities- Interact with the community and employees
- Support and participate in other company initiatives as directed by senior management
- Enter data into databases
- Follow SOPs and other applicable laboratory or company procedures
- Maintain confidential information
- Ability to navigate critical reporting software systems (MSWord, Excel, Provantis) and work with scanned document image files.
- Review study protocols and amendments, prepare reporting schedules, and participate in study meetings.
- Monitor critical phases of study and interact with toxicology staff and subcontractors, as needed, for compliance with protocol, SOPs and applicable regulations.
- Perform periodic reviews of study data and prepare data summaries for Study Directors and clients as required.
- Compile data tables and materials/methods for multiple toxicology reports and data packages, concurrently.
- Verify findings and review raw data, consulting the Study Director regarding any abnormalities.
- Address applicable findings from QA audits and coordinate receipt of responses from operational groups.
- Work with Study Director to incorporate client comments into a revised draft.
- Oversee disposition of study specimens, i.e., test article, formulations, blood samples, preserved tissue.
- Finalize study report and coordinate archiving activities.
Qualifications
* B.S in a scientific discipline (chemistry preferred) or
* At least 2 years of direct work experience in a scientific environment (regulated setting preferred).
* Equivalent combination of related education and required work experience will be considered.
Preferred skills and abilities:
* HPLC knowledge.
* Familiar with Microsoft Office Excel and capable of learning new software packages.
* Excellent organizational skills.
* Excellent oral and written communication skills.
* Ability to use a personal computer to write reports and verify calculations.
* Ability to comprehend and apply applicable government regulations (i.e. cGMP, cGLP, cGCP, OECD).
* Ability to adhere to all safety regulations and procedures.
* Ability to interact with scientific staff at all levels.
*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.
Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.
Inotiv has been named a 2023 Top Workplace!
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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