Associate Director – Project Management

This is a fully remote position, open to applicants in Canada.

📋 Description

• Supervise the planning, communication, and execution of clinical research and development services.

• Train, manage, and oversee Project Managers, including conducting performance evaluations.

• Review new applicants for Project Manager positions and recommend candidates for interviews in collaboration with the President.

• Create, update, and review governing documents for the functional area.

• Strategize and implement new client service delivery requests while supporting the evolution of the existing client portfolio.

• Further develop and establish project management policies and standard operating procedures (SOPs) to ensure quality deliverables.

• Facilitate project planning, task identification, deliverable identification, resource assessment, and utilization.

• Monitor project progress utilizing strategic planning and project tracking tools and methodologies.

• Provide monthly status reports on project progress.

• Conduct project status meetings to identify issues that require follow-up or immediate action.

• Ensure seamless project initiation, continuation, and successful completion in collaboration with functional area directors and managers.

• Engage with clients regarding resource requirements and project management objectives.

• Manage projects related to data management, statistics, medical writing, subject randomization and drug supply management (IWRS), data monitoring, adjudication committees, and regulatory submissions.

• Define work scopes, estimate budgets, and develop as well as manage cross-functional project work plans, resources, budgets, quality deliverables, and timelines.

• Oversee Phase I–IV clinical trials in compliance with ICH guidelines, FDA, Health Canada, EMA, and other relevant regulations.

• Lead cross-functional project teams.

• Manage project planning, implementation, execution, and reporting while adhering to timelines, budgets, quality standards, and regulatory requirements.

• Coordinate activities between Everest, trial sponsors, support groups, and vendors.

• Monitor financial status against budgets and reconcile expenses across activity sub-streams.

• Track tasks against timelines and hours spent compared to budgets, alerting management to any major deviation risks.

• Prepare project status reports and present updates to internal and external stakeholders.

• Facilitate meetings, problem-solving sessions, and conflict resolution efforts.

• Communicate action items and key decisions through minutes and follow-up actions.

• Conduct lessons-learned meetings.

• Contribute to or participate in the performance evaluations of staff.

• Assist with Requests for Information and Requests for Proposals, including work scopes, budgets, and contract administration as necessary.

• Execute clinical trial planning, management, and site monitoring from trial initiation to closure as needed.

⛳️ Requirements

• B.Sc. or M.Sc. in a life sciences or health-related field.

• A minimum of 12 years of experience in clinical research and development within a pharmaceutical, biotechnology, or CRO environment.

• Experience in line management is essential.

• Proven ability to lead and mentor others within the functional area.

• Strong 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 of ICH guidelines, FDA, Health Canada, and EMA regulations.

• Ability to define project scopes, estimate budgets, and manage projects, including resource requirements and utilization, hours spent versus budgets, key deliverables, and timelines.

• Demonstrated leadership capabilities, including setting goals for others and driving achievement in alignment with allocated resources, timelines, and budgets.

• Excellent interpersonal, oral, and written communication skills.

• Proven negotiation and presentation skills.

• Strong problem-solving skills, including conflict resolution capabilities.

• Experience as a clinical trial monitor, with skills in initiating, monitoring, and closing clinical trials, is preferred.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life and AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee Assistance Program (EAP).

• Pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.

• Remote work from a home-based office anywhere in Canada, in accordance with the Work from Home policy.