Project Manager II (Romania)

About the Role

The Project Manager II has overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. This role oversees and coordinates study resources to ensure compliance with study budget, project scope and timelines in accordance with applicable standard operating procedures (SOPs), good clinical practices, and regulatory requirements.

Why This Role

• Work for a mid-sized CRO on significant multisite trials, including Global Phase III projects
• Position yourself in an environment where you can grow your career alongside the company

Key Responsibilities

Client Interactions

• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively

Project Planning

• Oversee and actively participate in preparation of project deliverables including study plans, protocol, informed consent forms, electronic case report forms (eCRF), and clinical study reports
• Participate in planning and conduct of Investigator's Meetings
• Ensure each site has necessary materials including investigational product, study supplies, and equipment
• Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor setup, and site contracting
• Collaborate with Regulatory Affairs on timely submissions and essential documents
• Partner with Data Management on CRF alignment and data review timelines

Quality and Risk Management

• Ensure assigned studies are audit ready at all times
• Monitor quality of study deliverables from vendors and SubCROs
• Manage risk and control measures for project quality
• Analyze discrepancies between planned and actual results
• Review and approve responses to quality assurance audits

Project Budget and Timelines

• Control project budget with attention to internal hours allocated
• Identify out of scope activities for change orders
• Proactively manage operational aspects including timelines, budget, resources and vendors
• Coordinate tasks and deliverables from all functional departments
• Manage and report on recruitment status