Senior Clinical Data Manager

Everest Clinical Research is a full-service contract research organization (CRO) serving pharmaceutical, biotechnology, and medical device industries. Based in Markham, Ontario, with additional sites in the United States, China, and Taiwan, Everest delivers high quality deliverables, superior customer service, and flexibility to meet clients’ needs. We are seeking a Senior Clinical Data Manager for our Toronto/Markham, Ontario, Canada on-site location or a home-based office anywhere in Canada in accordance with our Work from Home policy. Responsibilities Lead data management activities, including development and maintenance of the Data Management Project Plan (Plan), documentation of deviations, issue logging, and resolution follow‑up. Serve as the primary contact for day‑to‑day data management activities and overall responsibility for all data management deliverables for assigned projects. Plan, implement, and communicate data management timelines and deliverables; provide status reports for database and data management activities; contribute to overall project planning, progress tracking, and reporting. Assist with study‑level resource planning and management, including review of team members’ timesheet reports. Perform client relationship management activities; participate in project bid defense meetings when required. Conduct training on EDC systems, data flow, and quality control processes for clinical trial personnel; provide training to new data management personnel and perform quality control reviews of work performed by less experienced team members. Assist in generation of project Work Orders and Amendments; manage data flow from and performance of Third Party Vendors (Non‑CRF data vendors). Participate in project kick‑off meetings, investigators meetings, and regular project management team meetings; provide support to client audits and regulatory inspections; follow up on audit findings. Create and maintain clinical trial Data Management Study Binders. Hands‑On Data Management Activities Design and review case report forms (CRFs/eCRFs) and completion instructions; develop and review annotated CRFs. Design and review clinical trial source document templates and completion instructions when required. Develop and maintain data validation specifications; develop and maintain the Data Management Plan (DMP) and document deviations from the DMP. Participate in the database design process and in EDC User Acceptance Testing (UAT); manage the process of database modifications after go‑live due to protocol amendments or study needs. Develop and maintain the Data Quality Review Plan (DQRP); coordinate with programmers to complete programming and validation of listings and summary tables as specified in the DQRP. Perform third‑party non‑CRF data management activities; review data, issue and resolve queries; assist site personnel with query resolution; perform serious adverse event reconciliation; assist in resolving medical coding discrepancies. Cooperate with the Quality Assurance Department on quality control audits; perform database soft‑lock and hard‑lock activities; maintain and prepare final archival of data management documentation relevant to assigned clinical trials. Qualifications and Experience Bachelor’s or Master’s degree in health, pharmaceutical, or related sciences (physical/biological/chemistry). At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 years as a Clinical Data Manager II, with demonstrated knowledge, experience, and ability to meet high quality standards and customer satisfaction. In‑depth understanding of clinical trial data management concepts, processes, and procedures; knowledge of pharmaceutical clinical trial regulations, industry guidance, conventions, and standards. Strong leadership in clinical data management activities and a desire to excel in leading data management projects. Estimated Salary Range: $100,000 – $130,000. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #J-18808-Ljbffr