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: 

1. Lead or support efficient management of projects with activities focused on one or more of Everest service areas/functional groups.
2. 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.
3. 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:
   1. 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).
   2. 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.
   3. 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. Coordinate activities between Everest and trial Sponsors and with various supporting groups or third party vendors (e.g., 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.g., third party vendor data transfers are planned for appropriately in the biostatistics and programming delivery timelines).
   4. 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.
   5. Proactively track and manage the financial status against work order budgets, hours spent, and tasks performed; reconcile expenses across sub-streams of activities (e.g., 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.
   6. Review and report on overall client portfolio performance (i.e., project delivery, quality, financial performance) and work with senior Project Management leaders to identify areas of opportunities and challenges to define continuous improvement plans.
   7. Generate new sales leads by developing trust-based relationships with client counterparts, with the goal of winning repeat and new business based on client relationships established. Identify opportunities to offer additional Everest services to grow an existing client account.
   8. Function as leading facilitator of problem solving and conflict resolution, working with functional leaders to drive strategic and effective decisions and plans.
   9. Communicate project action items and key decisions through timely minutes and follow up actions.
4. Support general operational and capability building activities for the Project Management department. These include, but are not limited to, the following:

• Assist in the development and/or revision of training materials, SOPs, technology enablement, and creation of templates and work instructions to develop standardization and streamlined approaches within the Project Management functional group.
• Manage and support the establishment and maintenance of project information repositories to support Everest business analytics.
• Work with Business Operations leaders to help lead assigned Business Development initiatives, including, but not limited to, the following:

1. Organize and coordinate responses to and preparation for RFI and RFP across different functional groups, which includes tracking and supporting the completion of:
2. Cost estimates by engaging respective functional group leaders and Business Development Team.
3. Proposal Development and writing, through the engagement of respective functional group leaders and compilation of key information and project assumptions to ensure quality and accuracy of proposal content.
4. Support bid defense preparation, including materials development (e.g., presentation slides).
5. Support contract development, including Service Work Orders, Change Orders, and any other project.

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