The Project Manager is a leadership role with lifecycle responsibility for Stemedica Clinical Sites. This includes site identification, budget, IRB approval, site qualification, documentation, coordination with CRO group, coordination with PI.
This position is responsible for the following:
• Responsible for overall leadership and project management for clinical sites;
• Manage project teams and schedules including PI, Hospital Staff, CRO Team members, Stemedica personnel;
• Support clinical sites in IRB approval;
• Support generation and approval of site budgets related to up front start up equipment, supplies, training.
• Monitor and audit clinical protocol binder, CRO performance, patient documentation, etc; must be willing to travel domestically and internationally as required as related to site visits and training.
A BS or BA in biology or equivalent is required, however exceptions may be made based on relevant industry experience. A minimum of 5-8 year of pharmaceutical industry experience is required. Familiarity with the cell therapy or a closely-related field is desirable.
Specific required skills include:
• Ability to manage and communicate cross functionally and at all levels within both Stemedica and Clinical Site organizational structures.
• Possess solid organizational, tracking, report generation skills.