Associate 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 Associate Director, Project Management leads project planning, communication, and execution for clinical research services, while overseeing Project Managers and Senior Project Managers, managing cross-functional clinical trial projects, and ensuring delivery within quality, budget, timeline, and regulatory requirements.

Responsibilities:

• Training, management, and oversight of Project Managers, including performance assessments
• In consultation with the President of Everest, review new Project Manager Applicants and recommend hires for interview processing
• Develop, update and review governing documents for use within this functional area
• Plan and implement new client service delivery requests within client portfolio; supporting evolution of existing client portfolio, providing holistic biometrics deliveries across multiple clinical development programs
• In consultation with the President of Everest, further develop and establish policies and SOPs in project management and assurance of quality deliverables
• Facilitate the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization
• Perform project progress tracking for responsible projects using strategic planning and project tracking methods and tools. Provide monthly project progress status reports for individual ongoing projects
• 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
• Conduct responsible project progress status meetings with individual project teams periodically, with focuses and close attention to the projects which require close follow up or immediate actions
• Through the periodic review meetings, issues such as lack of planning, lack of resources, poor team performance, or other external factors negatively impacting the ongoing projects, are promptly identified and brought 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 the President of Everest, interact with clients for projection of resource requirements and project management purposes
• Manage projects with activities focused on data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies
• Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines
• Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to 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
• Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary
• Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities
• Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations
• Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders
• Function as meeting facilitator for the meetings involving various internal and external participants
• Function as facilitator of problem solving and conflict resolution
• Communicate project action items and key decisions through timely minutes and follow up actions
• 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, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities
• When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure

Requirements:

• B.Sc. or M.Sc. in life sciences or health related field
• 12+ years' experience in clinical research and development within a pharmaceutical, biotechnology 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, 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
• Experienced as a clinical trial monitor, initiating, monitoring and closing out clinical trials will be desirable