Clinical Research

• The LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level
• Managing the consistency of Local Trial Management duties and processes
• Serve as the country-level single point of contact on the study for internal partners
• Manage and oversee Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable
• Execution of local milestones from feasibility through study close out
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM)
• Inspection Readiness and AQR at the country level
• Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary
• Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

Clinical Trial Manager

• Provide operational leadership for externally funded clinical trials and investigator-led research in ALS, SBMA, and other neuromuscular conditions.
• Strengthen clinical trial operations, support study start-up and implementation, and build capacity for future neuromuscular clinical trials.
• Ensure studies are delivered safely, efficiently, and in compliance with protocols, ethics approvals, sponsor expectations, and applicable regulatory requirements.
• Collaborate with clinician investigators, research associates, clinical research coordinators, research assistants, Alberta Health Services, NACTRC, sponsors, and regulatory partners to support research activities.

Clinical Research Manager

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post-activation through site closeout.
• This may include patient recruitment, investigator payments or other related activities.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
• Ensures access and audit trail reviews are conducted as required.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and/or tracking tools.
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
• Document requested revisions and approvals in CTMS.
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
• Provides solutions for obstacles in protocol execution and site management.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• Supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
• May develop and support execution of corrective action plans at site and study level.
• Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance including strengths as well as areas for development.

Clinical Trial Manager I

• Lead efforts in resolving day to day work related issues
• Provide statistical expertise for design, analysis and reporting of clinical trials
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP
• Provide statistical input to Case Report Forms (CRF) design
• Properly archive study files in accordance with trial sponsor’s requirements.

Senior Biostatistician

• Independently executes statistical aspects of projects that meet client expectations.
• Provide one-on-one mentorship to new employees and coops.
• Assists in the training of junior statisticians to develop methodological expertise, soft skills, and other aspects of professional development.
• Development of statistical analysis plans.
• Conducts statistical analyses.
• Report development.
• Interpretation and dissemination of findings.
• Oversees and implements quality control activities.
• Lead or participate in the develop or modification of novel statistical analysis code.
• Creates, maintains, or extends R packages and R shiny applications to standardize common statistical routines and enable their accessibility, using Git for version and BitBucket for collaboration.
• Participating in meetings with clients and/or internal project teams to lead discussions around statistical methods and to present results from analyses.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.

Clinical Research jobs in Canada

See all jobs on JobTailor

Clinical Trial Manager

Clinical Research Manager

Clinical Trial Manager I

Senior Biostatistician

Biostatistician II