Clinical Project Manager (Early Clinical Development, Home-Based)
About The Position
The Clinical Project Manager is responsible for the successful planning, implementation, and execution of contracted clinical trial activities, ensuring accurate transfer of contracts from proposal through project completion. The role provides functional leadership for project team members and maintains client communication, process documentation, and compliance with Good Clinical Practices and IQVIA Biotech and sponsor procedures. It also supports department leadership with training development, standards, department goals, and process improvement. The position manages full-scope regional and global projects, oversees project teams and assigned support staff, and is accountable for project scope, timelines, change management, reporting, and adherence to contracts, SOPs, and working practices. The manager identifies study trends and potential obstacles, develops mitigation solutions, sustains client relationships, and contributes to proposals, contract execution, internal process development, staff feedback, and project-level training compliance. Current knowledge of FDA regulations, ICH guidelines, and GCP is required.
Requirements
- Nursing or university degree at the US bachelor level or equivalent in a health-related field, with at least three years of direct clinical trial experience in a CRO or research-related organization and at least one year of management experience; or equivalent education and experience.
- Clinical Monitoring or Data Management experience.
- Excellent verbal and written communication and presentation skills.
- Ability to work independently, prioritize, and work in a matrix team environment.
- Working knowledge of Microsoft Word, Excel, and PowerPoint.
- Ability to travel domestically or internationally as required.
- Knowledge of the clinical research process from Phase I through regulatory submission.
- Strong organizational and interpersonal skills and ability to interact with staff at all levels.
- Ability to manage multiple priorities across clinical trials.
- Ability to reason independently, assess clinical settings, and recommend solutions.
- Ability to set baseline targets, track trends, and implement mitigation plans.
- Understanding of basic data processing functions, including electronic data capture.
- Working knowledge of current ICH GCP guidelines.
- Ability to secure a credit card cosigned by IQVIA Biotech.
Nice To Haves
- Previous experience managing people in a scientific or clinical environment.
- Prior experience with electronic data capture.
- Experience in contract and timeline management.
Responsibilities
- Manage full-scope regional and global clinical projects and provide project team leadership.
- Build and maintain positive client relationships, communicate clearly, and keep project reporting current.
- Negotiate with clients to maintain operational processes and ensure projects remain within scope.
- Review study trends, anticipate obstacles, and develop early warning systems and solutions to project challenges.
- Identify and document training requirements in learning management systems and ensure compliance with study-specific training requirements.
- Manage change on assigned projects and ensure projects follow applicable SOPs, working practices, and contract requirements.
- Ensure project timelines are met as specified in contracts.
- Identify processes needing updates and report them to the direct line manager or divisional lead.
- Keep executive management informed about assigned work and project status.
- Assist management in developing, documenting, and updating internal processes, SOPs, working practices, and quality assurance forms.
- Provide other project support to managers as assigned and oversee delegation of support staff activities as necessary.
- Assist with the development and delivery of capability and proposal defense presentations to prospective clients.
- Support Contracts and Proposals with final project contract execution and project-team CIS documentation; represent senior management in contract negotiations as appropriate.
- Provide timely and accurate feedback on team-member performance as part of the performance appraisal program, at least annually.
- Maintain current knowledge of FDA regulations, GCP, and ICH guidelines for clinical research.
- Maintain personal currency documentation for IQVIA Biotech SOPs, complete CAPA activities, and maintain timesheets; ensure back-up PM coverage when out of office.
Benefits
- Health and welfare benefits may be offered.
- Incentive plans, bonuses, and/or other forms of compensation may be offered, depending on the position.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
