Clinical Supply Leader

Clinical Supply Leaders at Parexel lead the Clinical Trial Supply & Logistics (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 including the delivery of projects/programs on time, to budget, to the highest quality and in compliance with ICH GCP, GCLP, customs regulations and GMP.

An employee in this position 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:

Operational Strategy and ExecutionDevelop & manage execution of project or program related clinical supply, sourcing, manufacturing, distribution & laboratory logistics strategy with relevant stakeholders in line with applicable regulations.Communicate with 3rd party providers and negotiate scope of work in conjunction with procurement.Utilize applicable tools for supply chain simulation and forecasting.Plan and manage inventory according to strategy, quantities and forecast.Create supply schedule, seek feedback from Clinical team on study progress and adjust accordingly by providing feedback to depots.Lead formal hand over meeting with the Proposal Support.Overview the operational management of programs and assets.Financial ManagementEnsure study/project timelines and budgets are met in accordance to the contract agreement.Maintain Parexel’s Internal Project controlling/Financial systems 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.Gather feedback and evaluate on the projects status and identify for any potential CIS (Change in Scope).PTC needed in a timely manner to ensure that the operational tasks are contractually covered.Follow through on any CIS until signature.Customer satisfaction and Client LiaisonAct as point of contact for internal and external customers.Proactively engage with external and internal clients in solution improvements.If required actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, contract negotiation and review) including client presentations.Represent Parexel at professional meetings/conferences as participant and/or speaker.Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situationsEnsure Quality and Process improvement Lead project meetings and support team members to monitor and ensure that projects is completed within budget, schedule and according to contract specifications in accordance to the quality standards, SOPs, ICH-GCP, GMP, GCLP, GDP and/or any other guidelines to fulfil local regulations, including customs regulations.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.Ensure that study specific management tools and central file maintenance plan are in place.Initiate project related training for project team members and ensure project team members adheres to processes established.QualificationsSkills:Client focused approach to workA flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to

detailOperational Leadership and Project management skillsProven strong business and commercial acumenProven consultative selling and negotiation, communication and customer management skillsProven leadership and interpersonal skillsAbility to Mentor, give work instructions, encourage, train and support team membersAbility to develop creative solutions for any Clinical Supply Chain aspect, incl. PLD servicesSound operational understanding of Clinical Studies and related Supply Chain aspectsGlobal team management and development skillsSelf- Motivated with a professional attitudeCapacity to work effectively in a matrix environment and value the importance of teamworkProficient use of MS office suiteWillingness and ability to travel as requiredExcellent interpersonal, verbal and written communication skillsGood understanding of the GxP regulatory frameworkKnowledge and Experience:Excellent understanding of logistics operationsExtensive experience of pharmaceutical/Clinical research/consulting industryProfound experience in laboratory logistics and/or clinical supply chain management or related field

within the biopharmaceutical industryStrong competencies in leading financial tasks such as budgeting, revenue recognition, change in scope analysis, cost negotiations, and financial metrics analysisProject management and/or significant team leadership experienceIndividuals should have a strong understanding of cross functional activitiesProfound multinational work experienceFluent in EnglishEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.