Data Management Specialist - Jobs in Laval, QC

Job Description

We are looking for a proactive, detail oriented Data Management specialist to join our Technical Support department . The Data Management Specialist participates in multiple clinical studies and is responsible to complete data management procedures and documentation from study setup to study closeout. Works in collaboration with internal and external clients to prepare/review/finalize study data file transfer specifications. Prepares, verifies, and transfers data files as scheduled.Working at Nexelis you will have the chance to participate in the daily life of the most successful advanced testing service provider in the immunology field. Involved in more than 15 SARS-CoV-2 vaccine developments in partnership with multinational pharmaceutical companies, innovative biotechnology companies and prestigious NGOs such as Bill and Melinda Gates Foundation or CEPI, we also proudly serve the needs of our clients in fields such as Flu (universal and seasonal), meningitis, respiratory syncytial virus, chikungunya, malaria, or HPV and are growing an immune-oncology franchise.If this position if for you, just submit your CV and we will contact you soon.Your main responsibilities;

• Performs study-specific data management tasks including the creation of internal data file specifications, setup of database conversion fields per data export requirements, and preparation and review of the associated documentation independently;
• Provides support for in-house data reviews by generating ad hoc database queries and extracting and converting the data to spreadsheet formats;
• Prepares and transfers data files according to established schedules/timelines, ensuring compliance with client and/or internal specifications, and the applicable quality assurance procedures for review, verification and documentation;
• Answers questions from regulatory authorities and client audits, if needed;
• Contributes to quality control by reviewing analytical procedures, procedure forms, or other related documentation to assigned studies. Follow and ensure the application of GLP, SOPs, special procedures and health and safety rules on their assigned studies.
• Performs all other related duties as assigned.

What we are looking for

• Bachelor of Science or a degree in a clinical or physical science or equivalent;
• 2 years experience in a Contract Research Organization (CRO) operating to Good Clinical Laboratory Practice (GCLP) standards and other regulatory experience, an understanding of clinical lab operations is a must.
• Knowledge of data file formats, file transfer methods, testing file export programs, documentation requirements working knowledge of database concepts and queries;
• Requires knowledge of laboratory and other information systems to facilitate data input, storage, and retrieval of information, data file generation and transmission to and from external clients;
• General knowledge of JAVA, SQL and CDISC Operational Data Model;
• Good organizational, time management skills;
• Excellent verbal and written communication skills

What we can offer

• Generous time off policy starting at three (3) weeks vacation and five (5) days of sick time
• Employee coverage on medical, dental and vision.
• Employee assistance program.
• Health expense account
• Generous bonus compensation policy

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