LIMS Clinical Studies Specialist -- (Full-time) -- Onsite -- Quebec CanadaContract Research Organization seeks a full-time onsite LIMS Clinical Studies Specialist with 2+ years' experience working within Clinical Research within a CRO. This person should have expertise in LIMS, and SampleManagement, Ligand Binding Assays, and/or Mass Spectrometry. Additionally, this individual should have a thorough understanding of Study Protocols and Plans from various phases of Clinical Trials (Phases

I-IV) and Safety Assessment (ideally Preclinical Toxicology Studies). Lastly, experience and knowledge having worked within a GLP and GCP environment and writing SOPs are also required. Opportunity offers competitive base compensation based on individual expertise and seniority.

Also offered are benefits, competitive PTO, and a Group RRSP with an employer match of 100% of individual contribution each pay period, up to 3% of annual salary. REQUIREMENTSCanadian Citizenship or Work Permit.

Location within Canada, ideally already local to Quebec. Ability to work full-time from organizational onsite location. Valid passport for US travel, as necessary.

BSc. Or higher degree in Life Sciences or related area. Experience working for a CRO and within regulated environments to include FDA, GLP, GCP and TPD.2+ years in Clinical Research with 1+ years exposure to LIMS.A history of working within Clinical studies coordination to include dealing with Study Protocols and Plans from various clinical trials (phases

I-IV), and Safety Assessments (Pre-Clinical Toxicology Studies). Experience with SampleManagement, Ligand Binding Assays and/or Mass Spectrometry. Knowledge of concentrations storage and reporting.

RESPONSIBILITIESPrimarily responsible for the coordination of study designs in support of internal/external activities within the organization. Supporting all users of Watson LIMS and study design related issues/questions; users include Watson Designers, Study Director/BPI, Sample Manager Teams, and Clinical/Pre-Clinical Sites. Performing sample reconciliation as needed.

Providing colleague training on study designs cross departmentally to include training documentation creation and updates, new employees on LIMS/study designs, and more. Supporting study design creation and employee training for other sites. Creating and verifying Watson LIMS study designs based upon study protocols, while coordinating design requests and assigning these to appropriate members.

Investigating and resolving issues related to study designs. Performing sample associations based upon sponsor manifests. Facilitating study designs for data reporting.

Contributing to study design assessment meetings to determine best approach in the creation of study protocols. Managing discrepancies related to sample reception. Authoring file memos, while ensuring proper execution.

Generating reports as required for various uses. Working with IT department to solve problems as well as with IT validation teams to perform UAT and test Cases.

Participating regularly within process improvement initiatives. Working closely with QC reviews and Sample Management teams, while also participating in SOP reviews and updates. Writing and editing SOPs as needed and conducting all work in compliance with SOPs as well as GLPs and GCPs, while observing all organizational guidelines and policies.

Ability to troubleshoot LIMS sample processing through the understanding of how samples are logged into, tracked and then maintained within the system.

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LIMS Clinical Studies Specialist