Country Study Operations Manager / Clinical Trial Manager - Canada - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Job reputed company The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study reputed company on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. Key Accountabilities Study Management reputed company Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables Serves as leader of the local study team (reputed company members, reputed company members, and other key stakeholders as required) on one or more studies Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and reputed company plans) May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or reputed company the pCRO responsible for these activities as applicable Liaises with SCP, reputed company SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission reputed company to Health Authorities (HAs) and Ethic Committees (reputed company) Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Accountable for reputed company of site activation escalations to study teams including offering reputed company for mitigation May be responsible and accountable for, as designated by the GSM Regional, country and study level recruitment reputed company Support of the development of study level plans Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and reputed company study delivery of the agreed plans Study and/or country vendor management and reputed company including follow up and coordination of vendor deliverables o Assurance of the follow up and coordination of regional and site reputed company events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc. Study Management Operations Acts as the reputed company of contact for reputed company study level questions for the local study team, ensuring reputed company at lowest possible level, and reputed company needed liaising with and escalating to appropriate global roles and teams May reputed company operational effectiveness initiatives at country or regional level Utilizes roles in country such as reputed company SCP, and expert roles such as reputed company Leads and SAPs, to reputed company the global teams with local intelligence and operational nuances to be considered Provides input on country level per subject costs, local vendor costs, and other fees where applicable Utilizes country intelligence to reputed company input on country specific risks into preparation of Investigational reputed company Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and reputed company of reputed company relevant compliance activities for allocated studies Supports implementation of reputed companys site technology experience systems Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote reputed company reputed company, remote reputed company data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial reputed company) Compliance with reputed company Standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with reputed company processes, ICH-GCPs and other applicable requirements Skills Expertise in the use of study and site .