Manage projects with activities focused on one or more of the following: clinical operations, 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.
Be the primary point-of-contact for clinical trial sponsors to ensure the timely initiation and completion of clinical projects.
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 the company and trial sponsors, and with various supporting groups or third party vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met.
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. Attend and present at bid defense meetings.
When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.
May provide support in Clinical Operations as required, such as the following:
- Assist in the development of study-specific training materials.
- Manage the process of setting up and maintaining the Trial Master File.
- Review/compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
- Assist with the preparation and negotiation of contracts with vendors and investigational sites.
B.Sc. or M.Sc. in life sciences or health related field.
Minimum of 8 years’ clinical research experience within a pharmaceutical, biotechnology, or CRO setting.
Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.
Ability to travel a maximum of 50% of working hours may be required.
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.
Fluency in French, including medical and scientific terminology, will be desirable.