Project Manager, Scientific Affairs

Job Summary Project Manager, Scientific Affairs is a subject matter expert in managing clinical and medical activities related to clinical trials operations, real-world data and evidence (RWD-RWE) generation, outcomes research (HEOR), medical writing, medical information call handling, and end-to-end pharmacovigilance activities. Duties And Responsibilities Clinical Trial Operations Collaborates with partnering Clinical Research Organizations (CROs), Clinical Research Sponsors, Health Care Organizations/Institutions or Pharmaceutical companies to ensure clinical trials support services are performed per Canadian regulatory standards. Reviews and supports clinical research studies including source document review and approval and visit coordination. Aids in the facilitation of nurse education for clinical research studies. Establishes and maintains customer and site relationship management with key members at partner companies and research institutions. Accepts referrals for clinical research programs and assesses completeness and accuracy. Provides administrative support as needed / Performs other duties as assigned. Provides input into the development, execution, and risk mitigation plan for Clinical Trial programs and supports Quality audits. Clinical and Outcomes Research Supports the design and conduct of real-world data (RWD) generation initiatives. Collaborates with internal and external stakeholders (i.e. Pharmaceutical Partners, CROs, Registries, Health Systems and Academia) for planning and execution of real-world evidence data generation. Provides input into the development, implementation of strategy and risk mitigation plan for the assigned projects in areas of RWE. Ensures that all projects are delivered on time within scope and within budget. Assists in the definition of project scope, objectives, requirement gathering involving all relevant internal stakeholders and ensuring technical feasibility. Meets with clients to document detailed requirements gathering and clarify specific requirements for each project. Ensures resource mapping, availability, and allocation for RWE studies. Reviews, provides input, and/or authors clinical research protocols for RWD/RWE initiatives not limited to protocols, journals, abstracts, papers, or articles in conjunction with internal and external partnerships or stakeholders. Conducts interviews with subject matter experts, healthcare thought leaders and providers about medical breakthroughs. Conducts frequent and thorough quality control checks on each submission. Ensures that documents adhere to the organization’s writing guidelines and are appropriately stored and organized. Reports and escalates issues/delays to management as needed. Manages the relationship with the client and relevant stakeholders. Performs other duties as assigned. Medical Information Calls Handles medical information calls and queries. Provides accurate and timely responses (verbal and/or written) to medical information queries. Supports development of standard MI inquiry responses and FAQs in consultation and collaboration with pharmaceutical clients as needed. Updates and maintains standard response/reference documents as needed. Conducts literature searches and reviews published evidence to formulate a response for complex medical inquiries that are not part of the standard reference documents. As part of Medical Information (MI) call handling, receives and shares pertinent data for adverse event (AE) and product quality complaint (PQC) processing and reporting to meet contractual obligations. Participates in coverage for escalated MI inquiry management after business hours. Supports the preparation of MI audits. Ensures that all key performance indicators for running a well-established and compliant Medical Information call center are met. End-to-End Pharmacovigilance Activities Perform all activities related to end-to-end pharmacovigilance including but not limited to intake, triage, full case processing, quality checks, submission to Health Canada and reconciliation. Conduct source data verification as per defined sample size and contractual obligations. Perform literature review as per defined search terms, market and frequency set up as part of contractual obligations and report relevant adverse events. Review Canada Vigilance Database and report related adverse events. Support preparation for PV audits and inspections and establish best PV practices. Perform other pharmacovigilance activities as needed. Qualifications Education Graduate or post-graduate or terminal degree in a scientific discipline. Experience Minimum 3 years of experience in leading Clinical Research or Clinical Research Program operations and other scientific studies/programs. Experience in conducting and managing RWD-RWE and Outcomes Research activities. 2 years of experience in handling Medical Information calls and adverse event reporting. Experience in conducting global and local literature searches and interpreting clinical data from published evidence. Other Skills And Abilities Ability to work as an individual contributor as well as a team member. Experience in managing multiple clinical content and clinical studies at various stages. Excellent attention to detail. Excellent verbal communication skills. Exceptional technical and medical writing skills. Exceptional organizational skills and time management. Strong knowledge of medical terminologies. Strong computer and software skills: Statistical software (e.g., SAS, SPSS, R), Excel, Word, Outlook, Adobe Acrobat, Visio, SharePoint, CRM database entry, VOIP telephony, web portals, teleconferences, web-based meetings, NAV, KROLL, and/or other pharmacy-related software systems. Able to triage priorities – what should be directly managed, what should be assigned to others, what should be escalated to senior leadership. Able to implement new processes and procedures effectively and efficiently. Able to communicate and present data with confidence to internal and external stakeholders. Familiar with PIPEDA and how it applies in a confidential patient environment. Knowledge of GDP (Good Documentation Practices), GMP (Good Manufacturing Practices), Good Clinical Practices (GCP), Health Canada GVP (Good Pharmacovigilance Practices), Medical Information practices, International Council for Harmonisation (ICH) guidelines, and ISO standards. Primary Location ON-Markham

Location: Markham, Ontario, CA

Posted Date: 8/14/2025