29 Aug
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Syneos
|
Winnipeg
Clinical Data Reviewer - Internal Medicine (US, CAN, UK Only)Updated: YesterdayLocation: Toronto, ON, CanadaJob ID: 25108930-OTHLOC-1510-2DRDescriptionThe Clinical Data Reviewer will collaborate with clinical teams to review participant level data for internal medicine studies, ensuring data readiness for key milestones and providing clinical insights throughout the study lifecycle.Job ResponsibilitiesEnsure data readiness for milestones such as interim and final analyses, snapshots, Data Monitoring Committee reviews and publications.Review participant level data across a study in adherence with CRF Completion guidelines and the Data Review Plan.Conduct point-to-point data checks and interpretive analysis to identify inconsistencies.Generate queries on discrepant data and follow through to resolution, escalating unresolved issues.Create and use data review best practices and associated tools to identify trends and safety signals.Identify protocol deviations during routine clinical reviews and appropriately escalated them.Follow relevant SOPs and regulations, maintaining training requirements and seeking continuous improvements.Collaborate with data management, clinical and site management and other study team members.Attend clinical and study meetings as necessary.QualificationsBachelor's degree or nursing degree preferred.At least 7 years of clinical research experience in the pharmaceutical industry; strong monitoringexperience a plus.Background in clinical monitoring or RN strongly preferred.Direct clinical review and query writing/resolution experience required.Knowledge sufficient to assess scientific and clinical validity of participant data.Prior EDC experience preferred.Proficient in reviewing large listings in Microsoft Excel (filter, sort,
data formatting).Basic understanding of how data fields/CRFs interact and impact analysis.Ability to work independently in a virtual setting and as part of a remote team.Ability to prioritize and adjust work priorities quickly to meet deadlines.Basic knowledge of data management including CRF design, electronic edit checks and data handling conventions.Good written and oral communication skills with solid attention to detail.BenefitsBenefits may include a company car or car allowance, health benefits (medical, dental and vision), company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions or bonuses based on performance, and flexible paid time off and sick time. Paid sick time eligibility may vary by state or municipality. Syneos complies with applicable federal, state and municipal paid sick time requirements.Salary Range$80,600 to $145,000Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The company may assign other tasks at its sole discretion. Equivalent experience, skills, and education may also be considered. The information herein complies with the legislation of each country in which the company operates, including the EU Equality Directive. The company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.SummaryThe Clinical Reviewer is a specialized role performing clinical review ahead of major project milestones, focusing on both point-to-point checks and interpretive analysis for comparative safety and efficacy trials. The role requires knowledge of therapeutic areas, investigational drugs, and the ability to assess data validity.#J-18808-Ljbffr
📌 Clinical Data Reviewer - Internal Medicine - $80,600 - $145,000 A Year - Remote (Winnipeg)
🏢 Syneos
📍 Winnipeg