• Manages the delivery of all technical and service aspects of projects and studies for clients.
• Determines the preliminary design of the study and evaluates and understands the study.
• Serves as the internal link within the company and will have direct contact with all internal departments and direct one on one contact with external customers.
• Initiates the involvement of appropriate departments, maintaining continuous communication with those departments, and ensures the work delivered to customers is of a consistently high standard.
• Attends Project Meetings at the business or customer site. Leads and represents the business at kick off meetings as required by the customer.
• Leads and facilitates customer teleconferences, visits and audits as required, and provides timely provision of customer reports and updates.
• Interacts with Quality Assurance/Regulatory personnel to drive Problem Reports to closure.
• Ensures customer needs are properly translated into quotation, and has responsibility to monitor and amend the quote and budget as required.
• Provides accurate and timely financial forecasting and reporting.
• Responsible for revenue recognition for projects and verifies final production information for Accounting Department prior to invoices release.
• Participates in cross-functional business process improvement activities as required.
• Works closely together with the account manager to gain overall customer satisfaction.
• Applies Good Manufacturing Principles in all areas of responsibility.
• Demonstrates and promotes the company vision.
Key Global Project Lead (GPL) responsibilities (if applicable):
• Manages and leads operational aspects of large scale clinical trial projects with the client and project management teams to ensure timely, coordinated risk mitigated delivery of projects and services.
• Serves as the Central Point of Contact for the customer at a project and/or program level.
• Defines joint project goals and objectives with the client.
• Provides end to end project management globally and cross-functionally across all services and is accountable for project delivery.
• Acts as the point of escalation and coordination for the customer and the project team members ensuring appropriate issue identification, resolution and risk management.
• Defines and tracks metrics; maintains unified Dashboards and reports on global project / program progress.
• Provides global financial information (forecast revenue, reporting).
• Leads project close out activities.
• Requires understanding and competent use of SOPs required by company Quality standards.
• Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
• Requires strong and effective communicator with the ability to effectively present information and respond to questions from groups of managers and clients.
• Requires ability to develop strong customer management skills; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations.
• Requires knowledge of all internal systems associated with projects (i.e. Salesforce, GPMS, Trackwise).
As a Global Project Lead (GPL), the following additional qualifications:
• Proven experience of working collaboratively in global multi function teams and ability to transition between roles effectively.
• Skilled across the full spectrum of project management techniques to build an integrated cross-functional plan with good working knowledge of project management tools and techniques.
• Ability to assess global situations to determine the importance, urgency and risks, and make clear decisions which are timely and in the best interests of the organization and the customer.
• Ability to speak, listen and write in a clear, concise, thorough and timely manner across sites and functions using appropriate and effective communication tools and techniques.
• Ability to overcomes obstacles and achieve key outcomes- follows through to get things done and delivers what is promised across all sites and functions.
• Requires accredited college, university or recognized professional degree, preferably in a health related field. Prefer advanced degree in a health related field.
• Requires 3 years of successful experience in clinical trial project management as a Project Manager or Coordinator.
• Requires in depth understanding of clinical trials.
• Requires strong interpersonal and communication skills to include excellent relationship building.
• Requires proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook).
• Requires proven experience with customers in a dynamic environment.
• Requires excellent communication, organizational skills and project co-ordination skills.
• Prefer proficiency in appropriate project planning tools e.g. Microsoft Project to communicate milestones and critical path activities and responsibilities.
• Mastery of basic Project Management concepts as a recognized institution in project management.
Work Conditions/Physical Requirements:
• Some locations require ability to work, on occasion, in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
• Must be able to lift and carry up to 50 lbs., on occasion.
• Must be able to use a computer up to 8 hours per day.
• 10 - 25% Travel, as needed.