Markham, ON, Canada
24 days ago
Project Manager, Scientific Affairs
*QUALIFICATIONSEducationGraduate or post-graduate or terminal degree in a scientific discipline.ExperienceMinimum 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 AbilitiesAbility 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.
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