Supply & Logistics Leader
Parexel
Bucharest, București, Romania
1 zi în urmă

The Supplies & Logistic Leader (SLL) acts as functional leader and will provide global leadership, management, general oversight and direction for Clinical Trial Supply & Logistics (CTS&L) projects.

This requires in-depth business understanding in order to make effective decisions independently and the knowledge and experience to confidently recommend a course of action.

The SLL leads the CTS&L teams by combining a depth of clinical & Lab logistics experience with insight into client pressures and an ability to develop the right solution for the client to achieve operational excellence, delivery of projects / programs on time, to budget, to the highest quality and in compliance with ICH GCP, GCLP, customs regulations and GMP.

The SLL has overall accountability for the development and execution of the Clinical Trial Supply and Logistics strategy and financial performance of the project.

May act as Project Leader for CTS&L standalone projects or for projects involving a small number of services, where no other PAREXEL Project Leader is assigned.

Activities

  • Review and approve project scope, timelines and budget for the contract development.
  • Identify and communicate project deliverables to all stakeholders
  • Ensure study / project timelines and budgets are met in accordance to the contractual agreement including proactive management and communication of timeline changes to ensure the efficiencies are maximized
  • Review, overseeing and management of the resources assigned to the project to ensure the CTS&L FTE assigned is appropriate and meeting the study’s requirement
  • Initiate project related training for project team members including but not limited to CTS&L staff
  • Perform risk assessment and develops mitigation / contingency plans as needed and manages project execution accordingly
  • Prepare, participate in and follow up on audits / inspections
  • Undertake the full range of project-based duties relevant to the leadership, management and development of the project team to ensure their performance meets and / or exceeds the requirements to be fulfilled both on the study as well as on a personal goals / objectives level
  • Communicate with 3rd party providers and negotiates scope of work in conjunction with procurement
  • Develop supply schedule, seeks feedback from Clinical team on study progress and adjust accordingly and provide feedback to depots
  • Lead formal hand over meeting with the Proposal Support
  • Overview the operational management of programs and assets
  • Ensures study / project timelines and budgets are met in accordance to the contract agreement
  • Maintain PAREXEL’s Internal Project controlling / Financial systemsincluding but not limited to monthly revenue and forecasting
  • Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers incl. invoicing
  • Gather feedback and evaluate on the projects status and identifyfor any potential CIS (Change in Scope) for professional and / orPTC needed in a timely manner to ensure that the operational tasks are contractually covered
  • Act as point of contact for internal and external customers and usea consultative approach in issue resolution
  • Support ongoing optimization of system infrastructure (systems used by CTS&L such as IPTrack,, LoMAS, processes, other internal tools) Implement process improvements, including CAPA, in conjunction with the team, in response to corporate, quality issues, client and team feedback and quality audits
  • Prepare, represent CTS&L project team and follow up on audits / inspections Performs risk assessment and develops mitigation / contingency plans as needed and manages project execution accordingly
  • Skills

  • Client focused approach to work
  • A flexible attitude with respect to work assignments and new learning
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Operational Leadership and Project management skills
  • Proven strong business and commercial acumen
  • Proven consultative selling and negotiation, communication and customer management skills
  • Ability to Mentor, give work instructions, encourage, train and support team members
  • Ability to develop creative solutions for any Clinical Supply Chain aspect, incl. PLD services
  • Sound operational understanding of Clinical Studies and related Supply Chain aspects
  • Global team management and development skills
  • Capacity to work effectively in a matrix environment and value the importance of teamwork
  • Proficient use of MS office suite
  • Willingness and ability to travel as required
  • Excellent interpersonal, verbal and written communication skills
  • Good understanding of the GxP regulatory framework
  • Excellent understanding of logistics operations
  • Extensive experience of pharmaceutical / Clinical research / consulting industry
  • Profound experience in laboratory logistics and / or clinical supply chain management or related field within the biopharmaceutical industry
  • Strong competencies in leading financial tasks such as budgeting, revenue recognition, change in scope analysis, cost negotiations, and financial metrics analysis
  • Project management and / or significant team leadership experience
  • Individuals should have a strong understanding of cross functional activities
  • Profound multinational work experience
  • Fluent in English
  • Education

  • Educated to B.A / B.S. or Master degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health related discipline, international trade, business administration or logistics or relevant work experience
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