[Hiring] Senior Project Manager @Precision for Medicine

Role Description

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

• 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.
• For projects of very limited scope, Sr. PM may assume all clinical activities.
• 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 and implementation of quality notification incident forms.
• Maintain integrated collaboration with all functional operations in the delivery of the program.
• 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.
• 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.
• Conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients.
• Ensure study specific training is implemented in collaboration with functional areas.
• Support business development and marketing activities as appropriate.
• Perform other duties as assigned by management.
• Remain compliant with organizational training, time-reporting, and any other administrative duties.
• Provide ongoing feedback for functional team members including annual performance reviews.

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.
• 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.

Requirements

• 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

• 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 must inspire and demand the highest standards from a professional and ethical perspective.
• Ability to lead and inspire excellence within a study team.
• Ability to create an environment where study team members have a sense of ownership.
• 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.

Salary Range

163,800-245,800/yr CAD