Remote CRO Project Manager II - Taipei, Taiwan — Columbus

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 — 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. This acquisition establishes a European footprint for Everest 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.

We are seeking a committed, skilled, and customer-focused 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's service areas/functional groups.
2. With the guidance of project leadership, ensure successful project team mobilization and communication throughout a project's lifespan to proactively track milestones, deliverables, and overall success. This includes:
   • Integrating information to develop project budgets for each in-scope service; developing and maintaining cross-functional project work plans, including identification of resource requirements, utilization, and deliverable timelines.
   • Preparing for and facilitating project kick-off meetings (internal and external), ensuring dissemination of key project assumptions and information to relevant stakeholders.
   • Implementing project management tools to ensure accurate tracking and transparency around project progress, expectations, and stakeholders — including communication plans, risk mitigation strategies, statistics and programming tracking sheets, etc.
3. Lead all project management aspects of assigned Phase I to IV clinical trials in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. This includes:
   1. Scheduling and conducting project meetings (internal and external); communicating assignments, priorities, and expectations to project team members across functional groups; and tracking completion of deliverables to ensure quality and timeliness. This includes preparation of meeting agendas and minutes, and scheduling/tracking of core project-specific training (e.g., protocol training).
   2. Serving as the primary point-of-contact for clinical trial Sponsors to ensure timely initiation of Sponsor-requests pertaining to active clinical projects.
   3. Coordinating activities across functional project teams; managing the planning, implementation, conduct, and reporting of assigned projects within established timelines and budgets. Coordinating activities between Everest and trial Sponsors and with third-party vendors (e.g., central laboratories) to ensure all contractual obligations are met and interdependent activities are effectively coordinated.
   4. Proactively tracking and managing project tasks against timelines and hours spent/budgets; preparing project status and progress reports; alerting management when there are risks of major deviations.
   5. Proactively tracking and managing the financial status against work order budgets, hours spent, and tasks performed; reconciling expenses across sub-streams of activities; monitoring to identify out-of-scope tasks and potential Change Orders.
   6. Reviewing and reporting on overall client portfolio performance (project delivery, quality, financial performance); working with senior Project Management leaders to identify opportunities and challenges and define continuous improvement plans.
   7. Generating new sales leads by developing trust-based relationships with client counterparts, with the goal of winning repeat and new business; identifying opportunities to offer additional Everest services to grow existing client accounts.
   8. Functioning as a leading facilitator of problem-solving and conflict resolution, working with functional leaders to drive strategic and effective decisions and plans.
   9. Communicating project action items and key decisions through timely minutes and follow-up actions.
4. Supporting general operational and capability-building activities for the Project Management department, including:
   • Assisting 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.
   • Managing and supporting the establishment and maintenance of project information repositories to support Everest business analytics.
   • Working with Business Operations leaders to help lead assigned Business Development initiatives, including:
     1. Organizing and coordinating responses to and preparation for RFI and RFP across different functional groups, including tracking and supporting the completion of cost estimates by engaging respective functional group leaders and the Business Development Team.
     2. Proposal development and writing, through engagement of respective functional group leaders and compilation of key information and project assumptions to ensure quality and accuracy of proposal content.
     3. Supporting bid defense preparation, including materials development (e.g., presentation slides).
     4. Supporting contract development, including Service Work Orders, Change Orders, and other project-related documents.