Watson LIMS Optimization Specialist - (Full-time) - Onsite - Quebec Canada Contract Research Organization seeks a full-time onsite Watson LIMS Optimization Specialist. Ideal candidate will have 2+ years' experience in Watson LIMS having worked within an FDA, GLP, GCP and TPD regulated environment prior. Additionally, this individual must have exposure to Sample Management, Ligand Binding Assays, and/or Mass Spectrometry. Ideal person will have worked within a CRO prior and possess strong communication skills both in English and French. 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.
REQUIREMENTS Canadian 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. 2+ years exposure to Watson LIMS. Experience working for a CRO and within regulated environments to include FDA, GLP, GCP and TPD. Exposure and history working with Sample Management, Ligand Binding Assays, and/or Mass Spectrometry. Proven history having performed most day-to-day responsibilities mentioned below.
RESPONSIBILITIES Serving as SME in the oversight of global activities required in support of Watson LIMS, with prior experience working and optimizing the WatsonLIMS. Collaborating with departmental management in the identification of user training needs, while then implementing these into the training program. Identifying key user training experts and coordinating training schedule. Ensuring continuous improvements to training program. Working with IT development teams to establish and prioritize validation and custom reports required, within an FDA, GLP, GCP and TPD regulated environment. Providing technical support to technicians, analysts and scientists. Investigating and troubleshooting errors for users with expertise having worked in SampleManagement, Ligand Binding Assays, and/or Mass Spectrometry. Working closely with IT in the reporting of bugs to vendor, while liaising to implement fixes, with the ability to communicate within both English and French as needed to vendor and other personnel. Assisting with Watson upgrade plans while ensuring proper deployment. Identification of Watson LIMS technical needs based on organizational business needs, and while ensuring system is utilized to its utmost. Working with IT validation teams in the approval of validation plans and change controls for instrument integrations, modules and adhoc tools. Participating on the customer advisory board for process improvement initiatives. Reviewing and updating SOPs while ensuring these harmonize across training sites. Conducting all daily tasks in compliance with SOPs, GLPs, GCPs, and all other organizational guidelines and policies. Managing licenses and procurement across all accounts to ensure proper security access, and to include onboarding and offboarding license tracking and assistance. Ensuring technical initiatives are justified based on capital and operational expenses.
BENEFITS Base Compensation dependent on individual expertise, current compensation and required needs. Medical Group Insurance Group RRSP with a 100% match of 3% of annual salary contributed each pay period. A Telemedicine program. 3 Weeks' Vacation. 6 Days PTO.
LIMS Clinical Studies Specialist - (Full-time) - Onsite - Quebec Canada Contract 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.
REQUIREMENTS Canadian 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.
RESPONSIBILITIES Primarily 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.
Watson LIMS Optimization Specialist – (Full-time) – Onsite – Quebec Canada Contract Research Organization seeks a full-time onsite Watson LIMS Optimization Specialist. Ideal candidate will have 2+ years’ experience in Watson LIMS having worked within an FDA, GLP, GCP and TPD regulated environment prior. Additionally, this individual must have exposure to Sample Management, Ligand Binding Assays, and/or Mass Spectrometry. Ideal person will have worked within a CRO prior and possess strong communication skills both in English and French. 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.
REQUIREMENTS Canadian 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. 2+ years exposure to Watson LIMS. Experience working for a CRO and within regulated environments to include FDA, GLP, GCP and TPD. Exposure and history working with Sample Management, Ligand Binding Assays, and/or Mass Spectrometry. Proven history having performed most day-to-day responsibilities mentioned below.
RESPONSIBILITIES Serving as SME in the oversight of global activities required in support of Watson LIMS, with prior experience working and optimizing the WatsonLIMS. Collaborating with departmental management in the identification of user training needs, while then implementing these into the training program. Identifying key user training experts and coordinating training schedule. Ensuring continuous improvements to training program. Working with IT development teams to establish and prioritize validation and custom reports required, within an FDA, GLP, GCP and TPD regulated environment. Providing technical support to technicians, analysts and scientists. Investigating and troubleshooting errors for users with expertise having worked in SampleManagement, Ligand Binding Assays, and/or Mass Spectrometry. Working closely with IT in the reporting of bugs to vendor, while liaising to implement fixes, with the ability to communicate within both English and French as needed to vendor and other personnel. Assisting with Watson upgrade plans while ensuring proper deployment. Identification of Watson LIMS technical needs based on organizational business needs, and while ensuring system is utilized to its utmost. Working with IT validation teams in the approval of validation plans and change controls for instrument integrations, modules and adhoc tools. Participating on the customer advisory board for process improvement initiatives. Reviewing and updating SOPs while ensuring these harmonize across training sites. Conducting all daily tasks in compliance with SOPs, GLPs, GCPs, and all other organizational guidelines and policies. Managing licenses and procurement across all accounts to ensure proper security access, and to include onboarding and offboarding license tracking and assistance. Ensuring technical initiatives are justified based on capital and operational expenses.
BENEFITS Base Compensation dependent on individual expertise, current compensation and required needs. Medical Group Insurance Group RRSP with a 100% match of 3% of annual salary contributed each pay period. A Telemedicine program. 3 Weeks’ Vacation. 6 Days PTO.
LIMS Clinical Studies Specialist – (Full-time) – Onsite – Quebec Canada Contract 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.
REQUIREMENTS Canadian 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.
RESPONSIBILITIES Primarily 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.
