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SeniorFull-timeGCP
Salary Range
$66,300 - $89,700 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are looking for a Project Manager to join Precision Medicine Group. This role involves planning, directing, and coordinating activities for clinical study projects to ensure objectives related to quality, scope, cost, and time are met.
Key Responsibilities
- →Serve as the primary point-of-contact and escalation point for clients
- →Coordinate and oversee all functional services, including external vendors, to established timelines and budgets
- →Manage study budgets and ensure projects remain within scope
- →Maintain collaboration with clinical operations and participate in clinical activities as appropriate
- →Manage the financial health of assigned studies, including profitability, billable hours, and billing compliance
- →Develop comprehensive project plans with timelines and risk management strategies
- →Ensure quality management for assigned projects, including eTMF inspection readiness
- →Establish tracking metrics to monitor trial and team progress
- →Prepare project status updates and reports for clients and senior management
- →Lead internal and client meetings and set expectations for the project team
- →Communicate effectively with clients and management regarding study issues
- →Conduct formal presentations to various audiences
- →Implement and ensure compliance with study-specific training
- →Support business development and marketing activities
- →Perform other duties as assigned by management
- →Remain compliant with organizational training and administrative duties
- →Provide ongoing feedback and annual performance reviews for team members
Requirements
- ✓Bachelor’s degree or equivalent in science or health-related field (Advanced degree preferred)
- ✓Minimum of 7 years of clinical research experience and 4 years of direct project management experience
- ✓Experience in managing complex and global trials
- ✓Ability to travel domestically and internationally
- ✓Experience with Microsoft Office Products, Microsoft Project, eTMF, EDC, and CTMS
- ✓Proven communication, interpersonal, and organizational skills
- ✓Knowledge of ICH-GCP, relevant SOPs, and project management techniques
- ✓Experience in a global, cross-functional project management environment
- ✓Understanding of project planning, risk management, and change management
- ✓High level of integrity and professional standards
- ✓Ability to lead and inspire a study team
- ✓Results-oriented with strong time management and critical thinking skills
- ✓In-depth experience in pharmaceutical and/or device research
- ✓Preferred: experience with oncology, cell therapy, and/or gene therapy
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