Senior Project Manager – Oncology

Responsibilities

• 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 oversees 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.
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate.
• 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 e TMF 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.
• Leads 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 implements necessary actions in response to those issues.
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency.
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project.
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required.
• Perform other duties as assigned by management.
• Remain compliant with organizational training, time-reporting and any other administrative duties as required.
• Provides on-going feedback, for functional team members including annual performance reviews.

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.
• Experience with Microsoft Office Products (Outlook, Word, Excel, Power Point), Microsoft Project, e TMF, 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.
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