Job Opportunity: Senior Project Manager I - Brightech (Taipei, Taiwan)

About Brightech & Everest Clinical Research

Brightech, an Everest Clinical Research Company, is a leading CRO specializing in complex, value-add biostatistics, programming, and clinical data management services. We have earned a highly-regarded reputation as a critical partner for major pharmaceutical, biotechnology, and medical device companies worldwide. Everest Clinical Research is a full-service CRO with a strong foundation and a history of growth since 2004. With headquarters in Markham, Canada, and additional sites in the USA, China, and Taiwan, Everest offers a broad range of clinical research services. The recent acquisition of August Research has expanded Everest's footprint into Europe, providing comprehensive full-service offerings across 14 countries.

Everest is recognized for its high-quality deliverables, superior customer service, and flexibility. We are a dynamic, entrepreneurial organization experiencing exceptional growth.

About the Role

To drive our continued success, we are seeking a committed, skilled, and customer-focused Senior Project Manager I to join our Brightech location in Taipei, Taiwan. This position also offers opportunities for remote work from a home-based office in accordance with our Work from Home policy.

Job Accountabilities

• Manage the full contract lifecycle from proposal to project completion, including end-to-end financial reconciliation.
• Oversee projects from initiation through closure for regional and global projects, encompassing site selection, study start-up, clinical operations, biostatistics, data management, IWRS, adjudication committees, pharmacovigilance, regulatory submissions, vendor management, and medical/scientific writing.
• Facilitate functional area directors and managers in project planning, task identification, and resource assessment.
• Track project progress using planning and tracking tools, providing monthly status reports.
• Ensure project plans are tracked and reported according to established SOPs and Working Instructions.
• Prepare and present project status reports to internal and external stakeholders, including comprehensive risk identification and mitigation strategies.
• Conduct project progress status meetings with project teams, focusing on projects requiring close follow-up.
• Identify project issues (e.g., planning, resources, team performance) and escalate them to functional area directors and managers, working collaboratively to ensure smooth project execution.
• Function as a meeting facilitator for internal and external participants.
• Serve as the project management lead interfacing with clients to drive project delivery, communication, problem-solving, and issue management; convey scope, resource requirements, financial and contracting statuses.
• Secure Sponsor approval for scope changes, assigned resources, and project decisions.
• Gain a clear understanding of contracted scope of work and initiate development and completion of out-of-scope work or change orders.
• Coordinate activities between Everest, trial Sponsors, and external vendors.
• Lead cross-functional project teams, managing implementation, conduct, and reporting within established timelines, budgets, and quality standards.
• Proactively track project tasks against timelines and budgets, alerting management to potential deviations.
• Facilitate problem-solving, lessons learned, and conflict resolution efforts.
• Track and manage the financial status against budget and reconcile expenses.
• Define scope of work and estimate budgets; develop and manage cross-functional project work plans.
• Manage all project management aspects of assigned Phase I-IV clinical trials in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory requirements.
• Communicate project action items and key decisions through timely minutes and follow-up documentation.
• Contribute to the development and establishment of policies and SOPs in project management.
• Participate in performance evaluations of staff working on assigned projects.
• Assist in responding to RFIs and RFPs, defining scope of work and budgets, and performing contract administration activities.
• Perform clinical trial planning, management, and site oversight from initiation to closure.
• Generate new sales leads by developing client relationships and identifying opportunities to offer additional Everest services.
• Available for up to 20% travel, including international travel.

Qualifications

• Bachelor of Science (B.Sc.) or M.Sc., or equivalent, in life sciences or a health-related field.
• Over 10 years of experience in clinical research and development within a pharmaceutical, biotechnology, or CRO setting.
• Minimum of 7 years of clinical pharmaceutical industry experience with demonstrated skills in clinical project management.
• Alternatively, candidates with >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.
• Knowledge of the clinical research process, including Phase I trials through regulatory submission.
• Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Demonstrated understanding of cross-functional processes, including site selection, study start-up, clinical operations, biostatistics, data management, IWRS, adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.
• Demonstrated leadership abilities, including setting goals and driving achievement within allocated resources, timelines, and budgets.
• Solid financial acumen, including the ability to define scope, estimate budgets, and manage projects, resource requirements, utilization, hours spent vs. budgets, deliverables, and timelines. Ability to identify out-of-scope work and initiate change order discussions.
• Excellent interpersonal, oral, and written communication skills. Strong negotiation and presentation skills.
• Strong problem-solving abilities, including conflict resolution.
• Fluency in French, including medical and scientific terminology, is an asset.

Location: Taipei, Taiwan (with remote work opportunities)

Join our winning team and contribute to groundbreaking clinical research!