Role Description To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Clinical Trials IWRS Monitor for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. This is a full‑time, permanent position providing overnight support, Sunday through Friday, from 11:00 p.m. to 7:00 a.m. - Act as primary contact with CTT Users for the Everest IWRS/IRT and eDiary team via the CTT Helpdesk telephone or IWRS helpdesk email accounts. - Support client request and issue analysis, problem solving, and resolution, working closely with CTT Developers and internal Everest Data Management and Statistical & Programming teams. - Monitor data generated within CTT applications to ensure accuracy and quality, including: - Daily checks of automated data queries built in the CTT applications. - Weekly manual checks of the data generated from the system. - Coordinate and verify changes to the database and application using appropriate change control procedures and ensure comprehensive and accurate documentation is completed. - Act as off-hours escalation point for junior IWRS Clinical Monitor resources or the outsourced call centre service to resolve high urgency client requests (based on agreed rotational schedule amongst IWRS Clinical Trials Monitor resources). - Generate, maintain, and/or review CTT Requirements Specification documents. - Execute CTT application test planning, test plan, and test script development and Stage I and II testing activities for CTT applications (newly developed applications or application change requests) in a systematic and detailed manner using the CTT Requirements Specification document as the base for testing CTT functionality. - Generate, maintain, and/or review Quick Reference Guides for all CTT studies. - Conduct CTT demonstrations to sponsors as well as training demonstrations to study team members. - Support communications and coordination with Sponsors, Study Team Members, Depot personnel and internal Everest data management and statistical leads across the IWRS development lifecycle. - Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on CTT applications. - Analyze CTT monitoring and support trends to identify new CTT core features that will improve efficiency, effectiveness, user satisfaction and market competitiveness to support CTT product development planning. - Provide analytical, report generation, and project execution support to CTT and Everest management team members for internal CTT capability development initiatives. Qualifications - A Bachelors’ degree in health science, physical or biological fields. - At least 3 years’ experience in clinical trial data processing and management. - Education or experience must demonstrate the ability to work independently. - Clear, professional and energetic telephone voice. - Detailed approach to data review and system development. Benefits - Robust benefits package to support health, well-being, and growth. - Medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. Company Description Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

Role Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Research Safety Associate for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. - Serve as the DMC Secretary and perform hands-on administrative tasks for assigned projects, according to Everest’s SOPs. - Assist with the identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments. - Serve as the liaison between the committee and the sponsor. - Write the committee Charter and its amendments and circulate for their review, finalization, and sign-off by the committee and Sponsor. - Assist with coordinating the preparation of the committee Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the committee members, according to the Charter. - Plan, schedule, and coordinate all committee meetings, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter, according to the Charter. - Support project management of DMC area with activities focused on planning and execution of DMC administration tasks and biostatistical support for these committees for assigned projects. - Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, with high quality and meeting regulatory requirements. - Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary. - Support medical writing and clinical safety monitoring teams by performing quality control (QC) review of document deliverables. - Under supervision, perform medical writing tasks, including writing of simple clinical study reports, simple study protocol, and other regulatory documents. - Perform data verification (QC) on statistical programming outputs against data sources. - Perform consistency review of document formats, styles, and overall layout according to a document style guide. - Learn and perform document e-publishing for clinical trial and regulatory documents. - May assist with case processing of safety events (SAE and/or pregnancy reports) from clients’ ongoing drug clinical trials. - Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH. Qualifications - M.Sc. or Ph.D. in a clinical or medical or health-related field. - At least two years' clinical research experience in an academic, pharmaceutical, or CRO environment. - Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards. - Experience with an accepted clinical data capture and management system (preferred). - Strong verbal and written communication skills with the ability to understand and summarize medical terminology. - Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines. - Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data. - Detail-oriented, customer- and quality-focused. - Excellent interpersonal and teamwork skills. - Computing skills in MS Office applications (preferred). - Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions (preferred). Benefits - Robust benefits package including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. - Estimated Salary Range: $60,000 - $85,000.

Role Description Under the direction of the Manager or Senior Manager, the Clinical Services Lead plays a vital role in the account team, driving partner satisfaction through continuous communication and effective project management. The Clinical Services Lead is responsible for ensuring partner deliverables are met during new implementations and ongoing projects by monitoring and prioritizing case workflows and addressing first-tier service issues. As a key member of the clinical leadership team, this role collaborates closely with Clinical Data Leads, Clinical Data Quality Specialists, the abstraction team, and Client Services management to ensure high-quality service delivery to our partners. Roles and Responsibilities - Oversee deadlines, team productivity, and case completion providing follow-up as necessary to ensure partner deliverables are met and target service line operational goals are achieved. - Coach team members on missed deadlines and inform SM/MCS of missed deadlines. - Create case assignments. - Monitor partner case volumes and hours to ensure teams are properly staffed to meet partner turnaround time, and request resource adjustments as needed. - Review key operating metrics to provide data driven recommendations to support business financial goals. - Serve as our partners’ primary point of contact for Client Services. - Maintain high levels of partner satisfaction by driving engagement and anticipating customer needs through ongoing communication, including scheduling and facilitating partner meetings and agendas. - Responsible for overall deliverables to partners including meeting deadlines, data submission agreements, and service agreements as outlined in the partner contract. - Champion the use of QC technology to streamline internal workflows and providing technology demonstrations for partners, as needed. - Proactively identify risk to partner satisfaction and escalate to SM/MCS. - Act as primary owner within Client Services for new implementations, reporting out on status when asked and serving as the point to solve implementation delays by working closely with the Project Manager and SM/MCS. - Participate in process improvement work to support overall Q-Centrix or Client Services department initiatives. - Discuss quality performance opportunities with partners to decrease fallout reviews or enhance quality outcomes. - Other quality tasks, as assigned. Qualifications - Strong analytical and critical thinking skills to approach problems in a systematic method using the ability to synthesize data and suggest recommendations. - Demonstrates high standards for accuracy and attention to detail. - Demonstrates technical savvy and adeptness to learn new systems and technology. - Thrives working independently and takes ownership of projects. - Consistently and clearly communicates, adjusting style and tone as needed to effectively collaborate with hospital partners, peers, abstractors and others. - Demonstrates strong self-organizational and time management skills to concurrently manage multiple accounts, adjusting as needed to shifting timelines and priorities. - Adapts to changes in project timelines, requirements, and assignments. - Maintains a high degree of responsibility in keeping PHI secure and confidential. Requirements - Familiar with hospital Core Measures and/or the Get With the Guidelines Stroke registry. - Intermediate proficiency with MS Office (Microsoft Excel). - Exposure to multiple patient medical record systems (EMRs) and clinical databases. - 1+ years providing coaching and guidance to teams (preferred). - Experience with evaluating operating financial metrics (preferred). - RN, LPN, RT, RVT, or RCIS credentials (preferred). Benefits - A fully remote work environment with flexible schedule and a generous Paid Time Off program with additional paid time for volunteering. - Robust benefits package including medical, vision, dental, health savings accounts, company paid short- and long-term disability, employee assistance program, paid parental leave, life insurance, accident insurance, and other voluntary benefit programs for employees and their eligible dependents. - 401(k) retirement plan with a company match. - Paid professional development hours and other supportive resources.

Role Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Biostatisticians working remotely from a home-based office in the United Kingdom in accordance with our Work from Home policy. Key Accountabilities: - Leadership and Project Management: - Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. - Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on time delivery of deliverables, earn client’s trust and repeat business. - Statistical Planning and Methodologies: - Provide statistical expertise for design, analysis and reporting of clinical trials and research projects. - Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes. - Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments. - Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects. - Provide input to unblinded data management plan when required. - Assist in research and development of statistical methodologies and processes. - Statistical Programming: - Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required. - Perform QC validation of analysis datasets and TLGs. - Perform third level review of dry runs and final run. - Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues. - Review and provide input to the Analysis Data Reviewer’s Guide, discuss and incorporate Data Standards Reviewer’s review comments to ensure quality of the document. - Statistical Analysis and Reporting, and Publication Support: - Perform statistical analysis as per SAP, and address peer/QC review comments and findings. - Perform statistical validation of core results, address additional QC validation comments and findings on the core results. - Plan and conduct or contribute to the trial results reporting/dissemination meetings. - Under supervision contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results. - Write statistical report or statistical sections of the CSR. - Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters. - Supporting Clinical Data Collection and Cleaning: - Provide statistical input to Case Report Forms (CRF) design and database/variable structure. - Provide statistical input to non-CRF data collection and acquisition methods and approaches. - Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification. - Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution. - Perform ongoing assessment and communication of data quality issues, including protocol deviations. - Assist data management and trial management team in preparing for database lock. - Complete job required and project-specific training. Comply with applicable Everest and trial sponsor’s policies, SOPs, and work instructions. - Properly archive study files in accordance with trial sponsor’s requirements. - Plan and carry out professional development activities. Qualifications - A Ph.D. degree in statistical science, mathematical analysis or related fields plus 2 years highly relevant experience or a Master’s degree plus 4 years highly relevant experience, with demonstrated ability and sustained performance. Company Description