Senior Project Manager - Oncology

Essential functions

• Serve as primary point-of-contact and primary escalation point to the client
• Coverage of all functional services including external vendors to the established timeline and budget
• Management of the study budget, ensuring project remains within scope and handling any out of scope activities appropriately. Drive CO to completion with support as needed.
• Maintain integrated collaboration with clinical operations in the delivery of the program and review of other study documentation
• Development of robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensuring Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings
• Establishing tracking metrics to monitor trial and team progress towards project goals
• Preparation of project status updates and reports on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Leading both internal and client meetings and setting expectations for the project team
• Communication of protocol/study issues including any deviations and implementation of necessary actions in response to those issues
• Supporting study-specific training implementation in collaboration with functional areas and ensuring compliance for the duration of the project
• Supporting business development and marketing activities as appropriate, including travel to Bid Defense meetings as required
• Performing other duties as assigned by management

Qualifications

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

Competencies

• Demonstrated knowledge of ICH-GCP, relevant Precision SOPs, and 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 lead and inspire excellence within a study team
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in 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 communications skills
• Good understanding of project management software
• In-depth proven experience in pharmaceutical and/or device research required
• Radiopharmaceutical trial experience strongly preferred
• Preferred: experience with oncology & cell and/or gene therapy