Associate Director, Project Management

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.