Senior Project Manager, Oncology

Overview

Plans, directs, coordinates and delivers designated clinical study projects so that objectives of quality, scope, cost and time are met.

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, ensuring the project stays within scope and out-of-scope activities are identified early and handled appropriately.
• 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, 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.
• Develop robust, comprehensive project plans, including timelines and proactive risk management and mitigation.
• 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 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 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.
• 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 maintain 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.
• 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 in a team setting.
• Proven organizational skills, attention to detail, and a customer service demeanor.
• Knowledge of ICH-GCP and relevant Precision SOPs, and 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; must inspire and demand the highest standards from a professional and ethical perspective.
• 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/or cell and gene therapy.

Details

• Location: Remote, United States.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.