|Project Manager, Clinical Research & Development|
(Clinical Project Manager)
(Clinical development Manager)
Our client, a Global CRO in Toronto, is looking for their next Project Manager who will be responsible for defining project scopes, estimating and managing budgets, planning, directing, and controlling project activities, managing resources, as well as overseeing project team performance of cross-functional teams engaged in clinical research and development activities.
This role will also allow the ideal candidate to interact daily with clients and internal personnel on data collection, medical writing, and regulatory standards.
Other key responsibilities include:
- 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 in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
- Lead cross-functional project teams by planning, implementing, 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, and alerting management when there are risks of having major deviations.
- Prepare project status reports maintaining accurate and current details, and present findings to internal and external stakeholders.
- Communicate project action items and key decisions through timely minutes and follow up actions.
- Function as meeting facilitator for the meetings involving various internal and external participants.
- Mediate and resolve any problems, issues, or conflicts that arise during the course of the project.
- Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
- Participate in the performance evaluation of staff assigned to projects under your management.
- May assist 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.
- May perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.
Qualification and Experience:
- B.Sc. or M.Sc. in Life Sciences or similar health-related field.
- 10+ years’ experience in clinical research and development within a pharmaceutical, biotechnology, or CRO setting.
- 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 is desirable.
- Fluency in French, including medical and scientific terminology, is desirable.