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.
Knowledge, Skills, Abilities
Understanding and competent use of SOPs required by company Quality standards.
Excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
Strong and effective communicator with the ability to effectively present information and respond to questions from groups of managers and clients.
Strong interpersonal and communication skills to include excellent relationship building.
Excellent communication, organizational skills and project co-ordination skills.
Ability to develop strong customer management skills; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations.
Knowledge of all internal systems associated with projects (i.e. Salesforce, GPMS, TrackWise).
Proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook).
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
3 years of successful experience in clinical trial project management as a Project Manager or Coordinator.
In depth understanding of clinical trials.
Proven experience with customers in a dynamic environment.
Advanced degree in a health-related field.
Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
The position is administrative, is positioned in an office environment and requires standing, bending, reaching, walking, and talking as well as exerting up to 20lbs of force occasionally
Thermo Fisher Scientific