[Hiring] Clinical Project Manager @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are a seeking committed, skilled, and customer-focused individual to join our winning team as a Project Manager for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

• Drive effective and efficient management of projects with activities focused on one or more of Everest service areas/functional groups:
• Clinical operations
• Data management
• Statistics
• Medical writing
• Clinical trial technologies (IWRS/IRT and eDiary/ePRO)
• Administration of data monitoring and adjudication committees
• Preparation of submissions to regulatory agencies
• Ensure successful project team mobilization and communication throughout a project’s lifespan.
• Integrate information to develop project budgets and maintain cross-functional project work plans.
• Prepare for and facilitate project kick-off meetings.
• Implement project management tools for tracking and transparency.
• 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.
• Schedule and conduct project meetings, communicate assignments, priorities, and expectations to project team members.
• Be the primary point-of-contact for clinical trial Sponsors.
• Coordinate activities across functional project teams.
• Proactively track and manage project tasks against timelines and budgets.
• Review and report on overall client portfolio performance.
• Generate new sales leads by developing trust-based relationships with client counterparts.
• Function as leading facilitator of problem solving and conflict resolution.
• Support general operational and capability building activities for the Project Management department.
• Assist in the development and/or revision of training materials and SOPs.
• Manage and support the establishment and maintenance of project information repositories.
• Work with Business Operations leaders to help lead assigned Business Development initiatives.

Qualifications

• Bachelor of Science or Master of Science in life sciences or health related field.
• Minimum of 8 years of clinical research experience within a pharmaceutical, biotechnology, or contract research organization setting.
• Fluency in Mandarin Chinese is required.
• Oncology experience is preferred.
• Experienced as a clinical trial monitor; initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.
• Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Ability to define scopes and estimate budgets and plan and manage projects.
• Demonstrated leadership abilities, including setting goals for others and driving to achieve them.
• Excellent interpersonal, oral, and written communication skills.
• Strong ability in problem-solving, including conflict resolution.

Benefits

• Medical, dental, and vision coverage
• Life & AD&D insurance
• Short- and long-term disability
• Tuition reimbursement
• Fitness reimbursement
• Employee assistance program (EAP)
• Pension plan
• Generous paid time off and sick leave
• Opportunity to earn a performance-based bonus

Company Description

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.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs.