Project Management

Full management of clinical development projects:

• Creates and executes project work plans and revises as appropriate to meet changing needs and requirements.
• Identifies resources needed and assigns individual responsibilities.
• Manages day-to-day operational aspects of a project and scope.
• Reviews deliverables prepared by team before passing to client.
• Effectively applies our methodology and enforces project standards.
• Ensures project documents are complete, current, and stored appropriately.
• Tracks and reports team hours and expenses on a monthly basis.
• Manages project budget.
• Determines appropriate revenue recognition, ensures timely and accurate invoicing, and monitors receivables for project.
• Follows up with clients, when necessary, regarding unpaid invoices.
• Analyzes project profitability, revenue, margins, bill rates and utilization.
• Assures follow up of  project legal documents.

• Registration files preparation (CTD format)
• Contact and advice from key opinion leaders from the preclinical and clinical fields