Senior Project Manager - Oncology

About the role

The Senior Project Manager at Pinnacle Method Consulting is responsible for planning, directing, coordinating, and delivering activities for designated clinical study projects. This role involves serving as the primary point-of-contact and escalation point to the client, managing the study budget, maintaining integrated collaboration with clinical operations, and leading both internal and client meetings.

Responsibilities

• 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 identifying and handling out of scope activities
• 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, to guide all parameters of trial execution with consistency and quality
• Ensure 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
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• 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, offering solutions and opportunities as they arise
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required
• Perform other duties as assigned by management

Requirements

• 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

Qualifications

• 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

Skills

• 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, project planning, risk management, and change management
• 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 can excel
• Ability to create and maintain a culture of continuous improvement

Benefits

• Competitive compensation package
• Flexible working arrangements
• Professional development opportunities
• Health and wellness programs

Pay

• $80,000 - $120,000 annually

Schedule

• Full-time