07 Nov
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Everest New Logo
|
Markham
07 Nov
Everest New Logo
Markham
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. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are a seeking committed, skilled, and customer-focused individual to join our winning team as a Project Manager for ourToronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. Drive effective and effective management of projects with activities focused on one or more of Everest service areas/functional groups: clinical operations, data management, statistics, medical writing, clinical trial technologies (IWRS/IRT and eDiary/ePRO), administration of data monitoring and adjudication committees, and preparation of submissions to regulatory agencies. With the guidance of project leadership, ensure successful project team mobilization and communication throughout a project’s lifespan to ensure and proactively track project milestones, deliverables, and overall success.
Integrate information to develop project budgets for each in-scope service and develop and maintain cross-functional project work plans, including identification of resource requirements and utilization, and deliverable timelines. Prepare for and facilitate project kick-off meetings (internal and external, as applicable), ensuring dissemination of key project assumptions and information to relevant stakeholders. Implement project management tools required to ensure accurate tracking and transparency around project progress, expectations, and stakeholders. This may include project communication plans, risk mitigation strategies, statistics and programming tracking sheets, and etc. Lead all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. Schedule and conduct project meetings (internal and external), communicate assignments, priorities, and expectations to project team members (across functional groups), and track completion of project deliverables to ensure quality and timeliness of all project-related tasks. In some cases, meeting minutes may be delegated to an Associate Project Manager or designee. This also includes scheduling and tracking of core project-specific training (e.protocol training).
Is expected to be the primary point-of-contact for clinical trial Sponsors to ensure the timely initiation of any Sponsor-requests that pertain to active clinical projects. Coordinate activities across functional project teams. Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, and with the quality required by Everest and general industry regulatory standards. central laboratory and other specialty laboratories) to ensure that all contractual obligations are met and that any interdependent activities are coordinated effectively and timelines planned for accordingly (e.third party vendor data transfers are planned for appropriately in the biostatistics and programming delivery timelines). Proactively track and manage project tasks against timelines and hours spent/budgets. Prepare project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders. Alert management when there are risks of having major deviations. project attrition reports). This includes monitoring to readily identify out-of-scope tasks and potential need for Change Orders, under the guidance of management/project leaders. Review and report on overall client portfolio performance (i.project delivery, quality, financial performance) and work with senior Project Management leaders to identify areas of opportunities and challenges to define continuous improvement plans. Identify opportunities to offer additional Everest services to grow an existing client account. Communicate project action items and key decisions through timely minutes and follow up actions. Support general operational and capability building activities for the Project Managem
📌 Clinical Project Manager (Markham)
🏢 Everest New Logo
📍 Markham