Senior Project Manager - Oncology
New
P
Precision for MedicineClinical research
Location: Remote, United StatesFull-TimeSenior
Salary$147,300 — $220,900 USD
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Job Details
- Experience
- Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience
- Required Skills
- Project ManagementMicrosoft OfficeRisk Management
Requirements
- Bachelor’s degree or equivalent combination of education and experience in a science or health-related field; an advanced degree is preferred.
- At least 7 years of clinical research experience or proven competencies for the position.
- At least 4 years of direct project management experience.
- Experience managing complex and global trials.
- Experience in a global, cross-functional project management environment.
- Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
- Experience with Microsoft Project, eTMF, EDC, and CTMS.
- Knowledge of ICH-GCP and relevant SOPs, with the ability to implement them.
- In-depth experience in pharmaceutical and/or device research.
- Understanding of project planning, risk management, change management, and escalation.
- Domestic and international travel, including overnight stays, is required.
- Oncology and cell and/or gene therapy experience is preferred.
Responsibilities
- Serve as the primary client point of contact and escalation point.
- Coordinate functional services and external vendors to meet established timelines and budgets.
- Manage study budgets, scope, out-of-scope activities, profitability, billable hours, billing, and forecasting.
- Develop project plans, timelines, and risk-management and mitigation plans for trial execution.
- Oversee project quality, eTMF inspection readiness, quality notifications, and corrective and preventive action plans.
- Establish tracking metrics and report project status, key performance indicators, progress, and solutions to clients and senior management.
- Lead internal and client meetings, communicate study issues and deviations, and implement necessary actions.
- Coordinate study-specific training and monitor training compliance throughout the project.
- Support business development and marketing activities, including travel to bid defense meetings as required.
- Provide ongoing feedback to functional team members, including annual performance reviews.
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