Project Manager, Clinical Trials Contractor

Responsibilities:

• Responsible for all activities related to the coordination and management of regional and/or global clinical studies 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
• 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 that to the direct line manager or divisional lead
• 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 defense presentations to prospective clients
• Supports Contracts and Proposals with final project contract execution and change in scope documentation by the project team.  Represents senior management in negotiation of contracts as appropriate.
• Maintains current knowledge of FDA and applicable regional regulations, and GCP and ICH Guidelines

Requirements:

• Nursing or University degree (US Bachelor Level or equivalent) in a health-related field
• Previous Project Management experience required
• Minimum of 2 years direct clinical trial experience in a CRO or research-related organization, preferred
• Project management experience within the medical device, diagnostic, SaMD development industry, with previous CRO experience, preferred 
• Previous or current experience in managing people within a scientific/clinical environment is required.
• Demonstrated financial management skills required
• Up to 20% travel may be required, including international travel
• Thorough knowledge of clinical research process from pre-clinical through regulatory submission, approval and post-approval
• Strong communication skills (verbal and written) to express complex ideas
• Excellent and demonstrated organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple priorities within a variety of complex clinical trials
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
• Ability to set baseline targets, track trends and implement mitigation plans
• Understanding of basic data processing functions, including electronic data capture
• Demonstrated problem-solving and financial negotiation skills 
• Excellent verbal and written communication and presentation skills required.
• Working knowledge of current ICH GCP guidelines
• The ability to work independently, prioritize and work within a matrix team environment is essential
• Working knowledge of Word, Excel, and PowerPoint required
• Prior experience in electronic data capture preferred