The IT Analyst, Electronic Submissions position is responsible for acquisition of study data from multiple data sources and process data through specialized software. Perform quality control review with great attention to detail on the resulting SEND dataset to ensure data accuracy. Correlate SEND datasets to ensure alignment with study report. Other duties include:
- Create SEND datasets for electronic submissions per client request.
- Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports in order to compare them with the electronic data and ensure the data is accurate.
- Manage standardized glossaries and co-ordinate with all other collection system glossaries administrators.
- Ensure work is compliant with applicable guidelines and regulations (e.g., CDISC SEND IG, SOP, GLP, etc
- Use independent judgement to provide solutions to inconsistencies between SEND data sets and study documentation or to escalate to management in a timely manner.
- Perform review and appraisals of computer software and associated products for electronic submissions.
- Assist in defining and delivering SEND e-data and quality controlled deliverables.
- Provide training and support as required.
- Provide support to users for data capture for electronic submission compliance.
- Assist with global system process change for electronic submissions compliance.
- Consistently deliver high-quality services to customers and manage customer expectations effectively.
- Communicate effectively with business to identify needs and evaluate alternative business solutions with project management.
- Perform all other related duties as assigned.
The following are minimum requirements related to the IT Analyst, Electronic Submissions position.
- Bachelor’s degree (B.A./B.S.) or equivalent in a scientific or related discipline.
- Minimum of one (1) year related experience in a scientific environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- This position requires analytical thinking skills and a good understanding of scientific data, as well as a general understanding of CDISC Standards.
- Proficiency with MS Excel required.
- Requires excellent communication and interpersonal skills.
- Requires great attention to detail. Ability to work well in a team environment.
- Knowledge of the Provantis system is a plus.
- Ability to adhere to timelines.
To apply for this position, visit: https://jobs.criver.com/job/Montreal-IT-Analyst-Electronic-Submissions-Q...
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 13,000 employees within 80 facilities in 23 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in 2017.
For more information, please visit www.criver.com.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet
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