Senior Project Manager, Oncology

Overview

Plans, directs, coordinates and delivers designated clinical study projects so that quality, scope, cost and time objectives are met, serving as primary point of contact and escalation point to the client.

What you'll do

• Serve as primary point-of-contact and primary escalation point to the client.
• Coordinate and oversee all functional services, including external vendors, to the established timeline and budget.
• Manage the study budget, keeping the project within scope and identifying and handling out-of-scope activities early; independently drive the CO to completion and execution with support as needed.
• Maintain integrated collaboration with clinical operations in delivery and participate in clinical activities as appropriate; for projects of very limited scope, the Sr. PM may assume all clinical activities.
• Manage the financial health of assigned studies, including project profitability, billable project hours, and on-time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality.
• Ensure quality management for assigned projects, including eTMF inspection readiness, quality notification incident forms and/or corrective and preventative action plans to address quality findings.
• Maintain integrated collaboration with all functional operations in program delivery and review other study documentation as necessary.
• Establish tracking metrics to monitor trial and team progress toward project goals.
• Prepare project status updates and report on progress to clients and senior management, including key performance indicators, offering solutions and opportunities as they arise.
• Lead internal and client meetings and set expectations for the project team.
• Communicate effectively with the client and Precision management to relay protocol/study issues, including deviations, and implement necessary actions in response.
• Conduct formal presentations to a wide variety of audiences, including colleagues, investigative staff and clients, including Bid Defenses.
• Ensure study-specific training is implemented in collaboration with functional areas and ensure study-specific training compliance for the duration of the project.
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required.
• Perform other duties as assigned by management.
• Remain compliant with organizational training, time-reporting and other administrative duties as required.
• Provide ongoing feedback for functional team members, including annual performance reviews.

What you'll need

• North America: Bachelor's degree or equivalent combination of education/experience in a science or health-related field.
• EU: Degree or equivalent combination of education/experience in a science or health-related field.
• 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.
• Experience in managing complex and global trials.
• Ability to travel domestically and internationally, including overnight stays.
• Experience with Microsoft Office products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS.
• Proven communication and interpersonal skills to interface effectively with others in a team setting.
• Proven organizational skills, attention to detail, and a customer service demeanor.
• Demonstrates knowledge of ICH-GCP and relevant Precision SOPs, with the ability to implement them.
• Direct work experience in a global, cross-functional project management environment.
• Good understanding of cross-functional management, project planning, risk management and change management, with awareness of appropriate escalation.
• Proven experience in strategic planning, risk management and change management.
• High level of integrity; inspires and demands the highest professional and ethical standards.
• Ability to lead and inspire excellence within a study team and create a sense of ownership that increases productivity and efficiency.
• Results oriented, accountable, motivated and flexible.
• Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills.
• Proven presentation, verbal and written communication skills.
• Good understanding of project management software.
• In-depth proven experience in pharmaceutical and/or device research.

Nice to have

• Advanced degree.
• Experience with oncology and cell and/or gene therapy.

Details

• Location: Remote, United States.
• Eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life and disability insurance, parental leave, and paid time off.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.