Job
Description
Job Description Summary 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. Key Accountabilities contract development. Identify and communicate project deliverables to all stakeholders. Project management Review and approve project scope, timelines and budget for the Engaging internal and external clients to develop logistics concepts and solutions in order to meet study deliverables, objectives and profitability while achieving client satisfaction 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 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 relevant stakeholders in line with applicable regulations Operational Strategy and Execution Develop & manage execution of project or program related clinical supply, sourcing, manufacturing, distribution & laboratory logistics strategy with 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 Develop and implement production, depot and distribution strategy including collaborating with 3rd party depots with relevant stakeholders Overview the operational management of programs and assets Maintain PAREXEL’s Internal Project controlling/Financial systems Financial Management Ensures study/project timelines and budgets are met in accordance to the contract agreement Finance and Profitability Management (Monthly, control, input) incl. client invoicing including 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 identify for any potential CIS (Change in Scope) for professional and/or PTC needed in a timely manner to ensure that the operational tasks are contractually covered Follow through on any CIS until signature Monitors the projects status and identify for any potential Change in Scope (CIS) needed in a timely manner to ensure that the operational tasks are managed Contributes to profitability/finance management (monthly reporting & forecasting, budget control, change in scope management Customer satisfaction and Client Liaison Ensure Quality and Process improvement 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 Proven leadership and interpersonal 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 Self- Motivated with a professional attitude 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 Knowledge And Experience 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 Show more Show less
