Clinical Project Manager / SCPM (CRO Services)

Job Title:   Project Manager or Senior Project Manager

Job Location:   Remote – United States or Canada  

Job Overview:   

The Project Manager fulfills the requirements of managing clinical trials to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Project Manager is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulations. The Project Manager is responsible for the overall execution of the project and may be the principal liaison with the client to ensure effective and timely communication of project progress, issues and plans for resolution of those issues.  

Special Note:  The title of Project Manager or Senior Project Manager will be based on the level of experience of the person hired.   

Job Duties and Responsibilities:

• Develops clear and measurable project management plan in conjunction with the Director, Clinical Operations – Project Management and Sponsor representative(s).
• Manage clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP. 
• Defines timelines, milestones and scope of work limitations to project staff.
• Establishes project metrics and project report schedules with client representatives. Provides at least monthly project updates.
• May act as the primary liaison between the project team and the sponsor/customers and service providers.
• ​Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks.
• Manages adherence to project budget and contracts and assists in the identification and development of scope change documents.
• Monitors project status, budget expenditures, and identifies problems and recommends solutions.
• Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
• Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team; regularly reviews budget/expenses with project team.
• Identifies out of scope work and initiates the scope change process with sponsor representatives.
• Ensures the site contract and budget negotiation process is completed in accordance with project timelines and coast parameters.
• Responsible for review and approval of project grants, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
• Accountable for development, oversight and delivery of project team training.
• Determines needed project processes, trains and maintains project team knowledge/application of project processes.
• Establishes and communicates team performance expectations and guidelines.
• Manages performance of a