Clinical Project Manager – Early Clinical Development

Posted 1 day ago

This is a fully remote position, open to applicants in Kansas, +9 more states.

📋 Description

• Plan, implement, and carry out contracted clinical trial activities.

• Oversee full-scope regional and global projects while leading project teams.

• Establish and nurture positive relationships with clients.

• Negotiate with clients, ensuring adherence to IQVIA Biotech operational processes and project scope.

• Analyze study trends and proactively engage with clients and team members.

• Create early warning systems to identify project obstacles and propose solutions.

• Recognize, define, and document training needs in LMS systems to ensure compliance.

• Manage changes across assigned projects effectively.

• Ensure that projects conform to SOPs, working practices, contracts, and timelines.

• Identify processes that need updates and convey them to management.

• Maintain client relationships, oversee current project reporting, and keep executive management informed.

• Develop, document, and revise internal processes, SOPs, working practices, and quality assurance forms.

• Offer project support to managers and supervise activities of delegated support staff.

• Assist in capability and proposal defense presentations.

• Support Contracts and Proposals with the final execution of contracts and CIS documentation.

• Participate in performance evaluations by providing feedback on team members.

• Stay updated on FDA regulations, GCP, and ICH Guidelines for clinical research.

• Provide project management backup during absences.


⛳️ Requirements

• Nursing or University degree (US Bachelor Level or equivalent) in a health-related field, with a minimum of three (3) years of direct clinical trial experience in a CRO or research-related organization, including at least one (1) year of management experience OR an equivalent combination of education and experience.

• Prior experience managing personnel in a scientific or clinical setting is preferred.

• Clinical Monitoring or Data Management experience is required.

• Exceptional verbal and written communication and presentation skills are essential.

• Capability to work independently, prioritize tasks, and collaborate within a matrix team environment.

• Proficient in Word, Excel, and PowerPoint.

• Previous experience in electronic data capture is preferred.

• Familiarity with contract and timeline management is preferred.

• Willingness to travel domestically or internationally as needed.

• Understanding of clinical research processes from Phase I through regulatory submission.

• Knowledge of current ICH GCP guidelines is essential.

• Must be able to obtain a credit card cosigned by IQVIA Biotech.

• Must keep current documentation for IQVIA Biotech SOPs, CAPA completion, and timesheet maintenance.


🏝️ Benefits

• Potential incentive plans, bonuses, and/or additional compensation options.

• Comprehensive health and welfare benefits.

• Flexible home-based work arrangement.

• Up to 20% travel, including opportunities for international travel.

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