Senior Project Manager

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

📋 Description

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

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

• Coordinate and manage functional services and external vendors in alignment with timelines and budgets.

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

• Collaborate with clinical operations and functional teams for study delivery and clinical activities.

• Create detailed project plans, timelines, and proactive risk mitigation strategies.

• Ensure project quality, eTMF inspection readiness, quality notifications, and corrective/preventive action plans.

• Establish tracking metrics for trial and team performance.

• Prepare project status updates and report KPIs and progress to clients and senior management.

• Facilitate internal and client meetings while setting expectations for the project team.

• Communicate protocol and study issues, deviations, and necessary actions.

• Conduct formal presentations, including bid defenses.

• Implement and monitor compliance with study-specific training.

• Assist with business development and marketing activities, including travel to bid-defense meetings.

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

• Fulfill assigned duties, organizational training, time reporting, and administrative requirements.

⛳️ Requirements

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

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

• At least 7 years of clinical research experience or demonstrated competencies for this role.

• Minimum of 4 years of direct project management experience.

• Experience in 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 interact with others in a team environment.

• Strong organizational skills, attention to detail, and a customer service attitude.

• Knowledge of ICH-GCP and relevant Precision SOPs, with the ability to implement them.

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

• Solid understanding of cross-functional management.

• Good grasp of project planning, risk management, and change management with awareness of appropriate escalation processes.

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

• High level of integrity along with professional and ethical standards.

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

• Proven skills in time management, negotiation, critical thinking, decision-making, analytical, and interpersonal abilities.

• Effective presentation, verbal, and written communication skills.

• Good understanding of project management software.

• Extensive experience in pharmaceutical and/or device research is required.

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

• 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.