Senior Project Manager - Oncology

Essential Functions

• 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 project remains within scope and that any out of scope activities are identified early and handled as appropriate
• Independently drive the CO to completion and execution with support as needed
• Maintain integrated collaboration with clinical operations in the delivery and participate in clinical activities as appropriate
• Manage the financial health of assigned studies, including oversight of project profitability, billable project hours, and compliance with on time, accurate billing and forecasting
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation
• Ensure quality management for assigned projects, including eTMF inspection readiness, implementation of quality notification incident forms and/or corrective and preventative action plans
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators
• Lead both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any 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 ensure study specific training compliance
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required
• Provide on-going feedback for functional team members including annual performance reviews

Qualifications

• Bachelor's degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for this position
• 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 effectively interface with others in a team setting
• Proven organizational skills, attention to detail, and a customer service demeanor
• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, and the ability to implement such items
• Direct work experience in a global, cross-functional project management environment
• Good understanding of cross-functional management
• Good understanding of project planning, risk management and change management with an awareness of appropriate escalation
• Proven experience in strategic planning, risk management and change management
• High level of integrity and ability to inspire and demand the highest standards
• Ability to lead and inspire excellence within a study team
• Results oriented, accountable, motivated and flexible
• Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Proven presentation, verbal and written communications skills
• Good understanding of project management software
• In depth proven experience in pharmaceutical and/or device research required
• Preferred: experience with oncology and cell and/or gene therapy