Project Manager II

Brightech is a leading CRO that specializes in complex, value-add biostatistics, programming, and clinical data management services. Brightech, an Everest Clinical Research Company, has earned a highly-regarded reputation as a critical partner for some of the world’s largest pharmaceutical and biotech companies. 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’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company’s substantive experience and infrastructure across 14 countries in Western and Eastern Europe. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. 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 seeking committed, skilled, and customer-focused individuals to join our winning team as a Project Manager II for our Brightech location in Taipei, Taiwan, with opportunities to work remotely from a home-based office in accordance with our Work from Home policy. JOB ACCOUNTABILITIES:  Lead or support efficient management of projects with activities focused on one or more of Everest service areas/functional groups. 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. This includes, but is not limited to, the following: 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. This includes, but is not limited to, the following: 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. This includes preparation of meeting agendas and minutes, with the support of key functional stakeholders. 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.g., 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 industr