Québec, Quebec, Canada
Acts as a primary contact with the client. Acts as a liaison and facilitator between other operation departments for project related tasks and/or issues. Plans and projects resources required across all areas of the study. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Develops and maintains project plans for the study. Performs ongoing review of project financial status of studies within his/her responsibility and a lerts senior management to potential issues and ensures necessary corrective action is taken. Prepares information for internal review meetings. Oversees the regulatory document collection and submission process. Ensures project documentation, including TMFs, are complete and audit ready. Managers outside vendors. 2. Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management. 3. Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and Customer presentations. Attends clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project plans. 4. Supports the Business Development department by participating in client proposal development as well as providing information on the Company's capabilities, patient populations, etc. May participate in proposal defense meetings. 5. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. 6. Acts as a liaison and facilitator between other departments within the Company to ensure project related tasks and/or issues are addressed. 7. Actively line manage other project management team members and may manage clinical monitoring staff.
Provide regulatory and study design recommendations for phase I bioavailability, bioequivalence, and first-in-human studies. Provides protocol writing and ICF development services.