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

Minimum Required: 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 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.

Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS. Proven communication and interpersonal skills. Proven organizational skills, attention to detail, and a customer service demeanor.

Competencies: 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, project planning, risk management and change management. Proven experience in strategic planning, risk management and change management. High level of integrity. 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 & cell and/or gene therapy.