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Clinical Supply CoordinatorJob ID 82100BR Argentina - Any Region - Home Based
Today we are looking for a Clinical Supply Coordinator to work remotely or partially from home in Argentina
As a Clinical Supply Coordinator, you will responsible for supporting the development and applying the study-specific supply chain strategy including the sourcing and distribution strategy for clinical trial supply to ensure that complex clinical logistics projects are set up and executed according to timelines, budgets, quality standards, SOPs and applicable ICH-GxP* and other applicable industry and regulatory guidelines to meet or exceed client expectations.
QualificationsAccountability Supporting Activities
- Support the development of the project specific supply chain Trial Supply Strategy incl. sourcing and distribution
- Utilize applicable tools for supply chain simulation and forecasting
- Plan and monitor inventory according to strategy, quantities, and forecast
- Support risk analysis
- Develop supply schedule and provide feedback to depots
- Defines with regional peers material specifications regarding the amount, lead times, local authorization, bill of material for project, and kits
- Utilizes available data regarding countries, sites, and enrolment data for appropriate planning and strategy
- Set-up and maintenance of inventory management systems (e.g.
- IVRS, IPtrack, etc).
- Perform UAT in close cooperation with the e-Logistics team.
- Provide input into development of documents, manuals, and quality documentation including GMP relevant documentation.
- Develop and plan inventory according to meet required strategy, quantities and forecasts
- Suggest and implement problem resolutions to meet required timelines.
- Project Execution
- Keep oversight of the progress of the trial and coordinate with CSL control requirements
- Support development of logistics concepts
- Support development of required study documents and systems according to project timelines and resources
- As needed, represent Clinical Logistics Services at client and internal project meetings
- Comply with Quality standards, including applicable SOPs and GxP* standards
- Perform key accountability tasks for Clinical Trial Supplies (IMP and Non-IMP) and for Ancillary Supplies
- Complain handling following GxP guidelines
- Support coordination of purchasing, manufacturing, distribution, return, recall, and destruction of medication for clinical trials, as applicable
- Incorporate the implications of local licensing and registration of medical devices for the distribution process and supply chain
- Supports Technical Logistics Coordinator in the development of specific technical solutions
- Collection of documents and QC on printability
- Performs QC on print product received and releases print runs Customer satisfaction
- Proactively engage external and internal clients in solution and Client Liaison improvements
- Ensure study/project timelines, budgets and efficiencies are met
- If requested actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, Contracts negotiation, and review) including client presentations
- If requested represent PAREXEL at professional meetings/ conferences as a participant and/or speaker
- Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situations
- Ensure Quality and Develop reports and statistics for studies and department
- Process improvement
- Support ongoing optimization of system infrastructure (systems used by CTS&L such as IPTrack, processes, PRXL internal tools)
- Address and follow up on quality issues and implement CAPA
- Collaborate with preparation and participate in and follow up on audits/inspections
- Implement process improvements, in conjunction with the team, in response to corporate, quality, client, and team feedback and quality audits
Ability to lead and build rapport with a culturally diverse group at multiple levels and disciplines
Strong client focus
Strong demonstrated ability to conduct business in English (written and spoken) and in the local language, if different from English
We offer you an excellent work environment as well as several development opportunities that you will get on your journey through our company.
In addition, you will have the opportunity to interact with outstanding professionals of different levels and cultures located around the world.
Looking forward to receiving your application
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