Position Summary:

The Project Director represents continued advancement upon the project management career track. Responsibilities are defined below and are dependent upon the type and timing of the program to which the Project Director is assigned but are generally associated with global or large studies or a program of studies. Commonly, the Project Director may be called upon to serve as Portfolio Manager of a suite of studies for a significant client. The Project Director is a critical position that may be called upon to support the Senior Leadership in ensuring continuous process improvement to support strategic company objectives in project execution.

Essential functions of the job include but are not limited to:

• Serve as primary point-of-contact liaison with client to provide outstanding customer service, including participation in proposal activities and client presentations
• Oversee and manages all aspects of a clinical research trial or trials, ensuring consistency across assigned portfolios.
• Provide direction to project managers assigned to their trials including project establishment, planning, initiation, procurement, execution and closing
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Drive any needed change orders to completion and execution with minimal support. Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop or oversee the 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. Able to implement strategic planning, risk management and change management with the ability to implement these independently
• 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.
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates for clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise. May be required to attend additional Senior management meetings, to offer further insight and presentations on assigned studies.
• Lead both internal and client meetings and set expectations for the project team, driving the program or study level strategies forwards with the project team
• Oversee the cross-functional project team, ensuring efficient management and execution of trials
• Communicate effectively with both sponsor 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 Defences with a high level of 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. As Project Director, proactively drive the Bid defense preparation activities.
• Perform other duties as assigned by management
• Remain compliant with organisational training, time-reporting and any other administrative duties as required
• Mentor associate project managers, project managers or Senior project managers as required
• Participate in the departmental updates, such as the development and updates of company SOPs as needed
• Provides on-going feedback for functional team members including annual performance reviews
• Identify any performance problem at a project level and ensure an operational corrective action is undertaken (training etc.)
• Ability to travel domestically and internationally including overnight stays

Qualifications:

Minimum Required:

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

Other Required:

• Minimum of 8 years of clinical research or proven competencies for this position. A minimum of 5 years direct project management experience

• Highly proficient with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Experience managing highly complex and global studies or a portfolio of studies

Preferred:

Competencies:

• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
• Excellent knowledge of project management techniques and tools
• Highly experienced at working in a cross-functional project management environment
• Strong understanding of cross-functional management
• Strong understanding of project planning, risk management and change management with an awareness of appropriate escalation
• 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. Motivates other members of the project team to meet timelines and project goals
• 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
• Demonstrated excellence in time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Demonstrated excellence in presentation, verbal and written communications skills
• Expert understanding of project management software
• Highly experienced in pharmaceutical and/or device research required
• Demonstrated expertise in strategic planning, risk management and change management with the ability to implement independently
• Highly developed customer orientation
• Highly developed influence, negotiation and conflict management skills
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make study processes more efficient and study teams more effective

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