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At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
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 indepth 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 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:
1.Project management
Review and approve project scope timelines and budget for the
contract development. Identify and communicate project deliverables to all stakeholders.
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 studys requirement
Perform risk assessment and develops mitigation/contingency plans as needed and manages project accordingly Prepare participate in and follow up on audits/inspections
Undertake the full range of projectbased 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
2.Operational Strategy and
Develop & manage 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 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
3. 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
Maintain PAREXELsInternal 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 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
4. Customer satisfaction and Client Liaison
5. Ensure Quality and Process improvement
Skills:
Knowledge and Experience:
Education:
Full-Time