Senior Project Manager – Remote CRO Role in Taipei — 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. August Research 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, extending full-service offerings and operational capabilities 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.

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 Senior Project Manager I 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. Assure the fulsome and accurate transfer of contracts from initial project proposal to project mobilization, through to project completion and end-to-end financial reconciliation.
2. Manage projects from initiation through closure for full scope regional and global projects, with activities focused on site selection, study start-up (including all systems and plan development), clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), administration of data monitoring and/or adjudication committees, pharmacovigilance, regulatory submissions, vendor management, and medical/scientific writing.
3. Facilitate the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, and assessment of resource needs and utilization.
4. Perform project progress tracking for responsible projects using project planning and tracking methods, tools, and software. Provide monthly project progress status reports for individual ongoing projects.
5. Check and ensure that responsible projects carried out at Everest will have a properly tracked and periodically reported project plan, as required by the established SOPs and Working Instructions.
6. Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders inclusive of comprehensive risk identification and sound mitigations.
7. Conduct responsible project progress status meetings with individual project teams periodically, with focus and close attention to projects that require close follow-up or immediate actions.
8. Through periodic review meetings, identify issues such as lack of planning, lack of resources, poor team performance, or other external factors negatively impacting ongoing projects, and bring them to the attention of functional area directors and managers.
9. Function as a meeting facilitator for meetings involving various internal and external participants.
10. Act as the project management lead interfacing with clients to drive project delivery, communication, problem solving, and issue management; convey scope and resource requirements, financial and contracting statuses, and other project management purposes. Seek Sponsor approval for scope changes, assigned resources, and project decisions when appropriate.
11. Gain a clear understanding of the contracted scope of work, and track and initiate development and completion of out-of-scope work or change orders with clients, in consultation with internal functional delivery teams, with the goal of ensuring Everest is compensated for additional scope/value delivered.
12. Coordinate activities between Everest and trial Sponsors, and with various supporting groups or vendors when necessary.
13. Lead cross-functional project teams. Manage the planning, implementation, conduct, and reporting of assigned projects within established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
14. Proactively track and manage project tasks against timelines and hours spent/budgets; alert management when there are risks of major deviations.
15. Function as facilitator of problem solving, lessons learned, and conflict resolution efforts. Share information with leadership where appropriate to improve the deployment of future projects.
16. Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities. Meet financial performance targets for assigned clinical projects.
17. Integrate information to define scope of work and estimate budgets; develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables, and timelines.
18. Manage 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.
19. Communicate project action items and key decisions through timely minutes and follow-up documentation.
20. In consultation with the Senior Project Management Leadership Team, review and contribute to further development and establishment of policies and SOPs in project management and assurance of quality deliverables.
21. Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
22. When required, assist the organization in responding to and preparing for RFI and RFP, and subsequently defining scope of work and budgets, as well as performing contract administration activities.
23. When required, perform clinical trial planning, management, and site oversight from the initiation of a trial to its closure.
24. Generate new sales leads by developing trust-based relationships with client counterparts, with the goal of winning repeat and new business. Identify opportunities to offer additional Everest services to grow existing client accounts.
25. Be available to travel up to 20%, including international travel.

Qualifications:

1. Bachelor of Science (B.Sc.) or M.Sc., or equivalent, in life sciences or a health-related field.
2. Over 10 years’ experience in clinical research and development within a pharmaceutical, biotechnology, or CRO setting. Minimum of 7 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks.
3. In lieu of the above requirements, candidates with more than 5 years of supervisory experience in a healthcare setting and 6 years of clinical research experience in the pharmaceutical or CRO industries will be considered. Clinical research site experience is a plus.
4. Knowledge of the clinical research process inclusive of Phase I trials through regulatory submission.
5. Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable.
6. Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
7. Demonstrated understanding of cross-functional processes including site selection, study start-up, clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.
8. Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
9. Solid financial acumen including the ability to define scope and estimate budgets, and plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables, and timelines. Ability to identify out-of-scope work and initiate change order discussions with vendors and Sponsors.
10. Excellent interpersonal and oral and written communication skills. Demonstrated strong negotiation and presentation skills.
11. Strong ability in problem-solving including conflict resolution.
12. Fluency in French, including medical and scientific terminology, is an asset.