Position Summary: The Project Manager manages and co-ordinates across all technical and service aspects of a project. This will range from initial discussions with clients, development of the project requirements, documentation aspects of setting up the project and management of all project related activities through to study completion.
- 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
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.
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