Senior Project Manager – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, direct, coordinate, and execute activities for designated clinical study projects to achieve quality, scope, cost, and time objectives.

• Act as the primary point of contact for clients and an escalation point for issues.

• Oversee coordination of functional services and external vendors in accordance with timelines and budget constraints.

• Manage study budgets, scope, out-of-scope activities, financial health, profitability, billable hours, billing, and forecasting.

• Collaborate with clinical operations and functional teams to ensure successful study delivery and clinical activities.

• Develop project plans, timelines, and strategies for risk management and mitigation.

• Ensure quality management, eTMF inspection readiness, quality notifications, and corrective/preventive action plans are in place.

• Create tracking metrics to monitor trial and team progress.

• Prepare project status updates and report key performance indicators (KPIs) and progress to clients and senior management.

• Lead internal and client meetings, establishing expectations for the project team.

• Communicate study issues and deviations, implementing necessary corrective actions.

• Conduct formal presentations, including bid defenses.

• Implement and monitor compliance with study-specific training.

• Support business development and marketing initiatives, including necessary travel for bid defenses.

• Provide ongoing feedback and conduct annual performance reviews for functional team members.

• Complete assigned duties, organizational training, time reporting, and administrative tasks.

⛳️ Requirements

• North America: Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field; advanced degree preferred.

• EU: Degree or an equivalent combination of education and experience in a science or health-related field; advanced degree preferred.

• A minimum of 7 years of clinical research experience or demonstrated competencies relevant to this position.

• At least 4 years of direct project management experience.

• Experience managing complex and global trials.

• Willingness to travel domestically and internationally, including overnight stays.

• Proficiency in Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS.

• Demonstrated communication and interpersonal skills to effectively engage with others in a team environment.

• Strong organizational skills, attention to detail, and a customer service-oriented approach.

• Knowledge of ICH-GCP and relevant Precision SOPs.

• Direct work experience in a global, cross-functional project management setting.

• Understanding of cross-functional management principles.

• Proven experience in project planning, risk management, and change management.

• High level of integrity and adherence to professional and ethical standards.

• Ability to lead and foster excellence within a study team.

• Strong time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.

• Excellent presentation, verbal, and written communication skills.

• Familiarity with project management software.

• In-depth proven experience in pharmaceutical and/or device research is required.

• Experience with oncology and cell and/or gene therapy is preferred.

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.