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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and 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 Director, Project Management 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.
Director, Project Management:
This leadership role will oversee the project planning, communication, and execution of clinical research and development services offered by Everest. Direct reports include all levels and roles within the Project Management department, including Associate Directors, Senior Managers, Managers, Senior Project Managers, Project Managers, Associate Project Managers and Project Coordinators. In-direct reports/subordinates are those Project Managers who are assigned to the tasks on the client studies and projects overseen by the Director of Project Management (matrixed organization).
JOB ACCOUNTABILITIES:
- Plan and implement new client service delivery requests within client portfolio; support evolution of existing client portfolio, providing holistic biometrics and full services (including clinical operations) project deliveries across multiple clinical development programs.
- Strategically align the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, and assessment of resource needs and utilization for existing and new clients/sponsors.
- Perform project and portfolio performance tracking for responsible projects using strategic planning and project tracking methods and tools. Conduct regular project progress reviews with internal teams for assigned portfolios, and facilitate conduct of Everest and Client governance meetings to optimize partnership expectations and performance.
- Check and ensure that responsible projects carried out at Everest are properly tracked and managed according to Everest’s quality, operational and financial budget standards. Support solution and budget development for complex and unique projects and scope to address client requirements.
- Provide leadership, training, mentorship, and management oversight of project management staff. This may include mentorship and training of team members to deliver project management services for specific client portfolios, or mentorship and career development of individuals in a line management capacity.
- In consultation with the senior Project Management leadership, review new Project Management Applicants and recommend hires for interview processing.
- In consultation with the senior Project Management leadership, further develop and establish policies and Standard Operating Procedures in project management for assurance of quality deliverables. Continue to support the development, update, and review of governing documents and WIs for the department.
- Initiate, drive, and support project management departmental process and technology improvement initiatives. Lead and contribute to developing reusable project management templates and training materials that can be used to improve effectiveness and efficiency of project delivery by other team members.
- Through the periodic project/portfolio review meetings, effectively identify issues such as lack of planning, lack of resources, poor team performance, or other external factors negatively impacting the ongoing projects, and bring the issues and solutions to the attention of the functional area directors and managers. Work with the functional area directors and managers to jointly ensure smooth project starting up, continuation, and successful completion.
- In consultation with Everest functional leaders and senior project management leadership, interact with clients for strategic partnership governance activities, which includes but is not limited to project pipeline and delivery planning, measuring performance metrics for the portfolio, identifying new project/service opportunities within the existing portfolio, implementing performance improvement and innovation initiatives, and obtaining key information to aid in the projection of resource requirements and project management purposes.
- Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
- Lead cross-functional project teams. Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
- Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations. Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
- Function as senior level facilitator of problem solving and conflict resolution, and act as a 2nd level escalation resource.
- Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
- Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
- When required, this position may assist the organization in responding to and preparing for RFI and RFPs, and subsequently leading and participating in bid defense meetings, defining work scopes and budgets, and leading contract administration activities.
QUALIFICATIONS:
- B.Sc. or M.Sc. in life sciences or health related field.
- A minimum of 18 years of experience in clinical research and development within a pharmaceutical, biotechnology, institutional, or CRO setting.
- Demonstrated ability to lead and develop others within functional area.
- Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, pharmacovigilance, 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, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
- Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
- Excellent interpersonal, oral, and written communication skills. Demonstrated strong negotiation and presentation skills.
- Strong ability in problem-solving, including conflict resolution.
Benefits & Compensation:
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com.
Estimated Salary Range: $180,000 - 230,000.
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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