Director, Project Management

Everest Clinical Research is a full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. The Director, Project Management will lead clinical research project planning, execution, governance, budgeting, and delivery while overseeing project management staff and cross-functional teams. The role also supports client partnerships, process improvements, regulatory compliance, staff development, and strategic portfolio management.

Responsibilities:

• 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

Requirements:

• 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
• Line management experience required
• 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