Clinical Project Manager

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.
We don’t make MedTech. We make MedTech happen.
Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency
The Clinical Project Manager is responsible for the successful planning, implementation, and execution of contracted activities.  Responsible for functional area deliverables of all team members throughout the duration of each clinical investigation.  Responsible for project timelines and managing financial health of assigned clinical investigation.  Ensure clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by RQM+ and our sponsors. Supports the department Head as needed in the development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.

Primary Responsibilities:

• Responsible for all activities related to the coordination and management of pre- and/or post market clinical investigations from start-up through close-out
• Partners with functional area leadership to ensure adequate resourcing and performance of the study team
• Leads, mentors, and motivates project teams towards executing projects to their highest ability
• Builds and maintains positive client relationships and serves as primary client contact
• Ensures projects are completed in compliance with RQM+’s operational processes and within scope of contracted timelines and budgets
• Maintains current knowledge of (EU) MDR 2017/745, (EU) IVDR 2017/746, ISO 14155, ISO 20916 and (EU) GDPR 2016/679
• Serves as point of escalation for client and study team regarding study issues and/or needs for improvement
• Reviews and identifies project study trends, developing appropriate early warning systems of potential obstacles and working with functional area leads to identify and evaluate risks, understand issues, and suggest and implement innovative solutions
• Identifies, defines, and documents training requirements in learning management systems (LMS) and ensures project level compliance with study specific training requirements
• Responsible for evaluation, client communication, and implementation of change management on all assigned projects
• Manages vendors and associated deliverables per scope of work
• Develops and manages study timelines and ensures timelines are met as per contract
• Develops and manages study budget, including forecasts, review/approval of vendor invoicing, oversight of project utilization, and review/approval of unit billing
• Develops and maintains project management documentation, including Project Management Plan, Risk Assessment and Categorization Tool, MS Project Timelines, monthly status reporting, etc
• Identifies processes in need of updating and documenting to the direct line manager
• Maintains client relationships for all assigned work, keeping project reporting current and ensuring executive management is aware of any performance risks
• In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, work instructions, and related quality documents
• Provides other project support to study team members, as required
• Oversees delegation of support staff activities, as necessary
• Assists in the development and delivery of capability and proposal defence presentations to prospective clients
• Supports Proposals and Contracts with final project contract execution and change in scope documentation by the project team.  Represents senior management in negotiation of contracts as appropriate

Requirements:

• University degree in a health-related field or similar medical or paramedical background
• Previous Project Management experience required
• Several years direct clinical trial experience in a CRO or research-related organization preferred
• Project management experience within the medical device, in-vitro diagnostic, SaMD development industry, with previous CRO experi