Title: Clinical / Biometrics Project Manager
Type: Permanent Role
- 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 Everest 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.
- At least 6-10+ years experience working in a Project Manager capacity, ideally with CRO experience
- We are looking for someone who can handle complex/demand clients and have the maturity to facilitate high level discussions but also connect the various cross-functional service delivery teams together as we are delivering on more full service offerings
- Someone who is self-driven and suitable/experienced in working remotely and is a strong communicator (communicates their needs, clear English communications skills as they will be primarily be more), but of course very presentable/professional in person as this role will be facilitating kick off meetings, investigator meetings…etc
- Someone who is hands on and demonstrates quality development of documents and presentations.
- Someone who can wear multiple hats and enjoy learning – as you know Everest is very entrepreneurial and team members who can take on unique tasks and flex with the business' needs will be valued and rewarded as such
- The travel expectation is not very high but approx. 15%-25% maximum (Bea correct me if I'm wrong).
- We prefer North American educated and experienced candidates who have proven experience working within the North American culture.