Supply and Logistics Coordinator

The Supply & Logistics Coordinator (SLC)/Senior Supply & Logistics Coordinator (SrSLC) is 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.

Key Accountabilities:

Project Planning Clinical Trial Supply Strategy

• Support the development of the project specific supply chain 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 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 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.
• (Senior) Support programs and assets

Project Execution and Control

• Keep oversight of the progress of the trial and coordinate with CSL 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
• Complaint 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 distribution process and supply chain
• Supports Technical Logistics Coordinator in development of specific technical solutions
• Collection of document and QC on printability
• Performs QC on print product received and releases print runs
• (Senior) Support programs and assets

Customer Satisfaction and Client Liaison

• Proactively engage external and internal clients in solution 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 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 Process Improvements

• Develop reports and statistics for studies and department
• 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

Accountability Supporting Activities

• Implement process improvements, in conjunction with the team, in response to corporate, quality, client and team feedback and quality audits

(Senor) 

• Identify and initiate process improvements
• Menor Clinical Supply Coordinators and Clinical Supply Specialists

Skills:

• 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 local language if different from English
• Good/Very good understanding of the drug development regulatory framework
• Good/Very good knowledge of Microsoft Office programs (Word, PowerPoint, and Excel)
• Multi-tasking and prioritization ability
• Result-oriented, confident, self-motivated, and driven/high energy
• Solid communication (verbal & written) and negotiation skills
• Ability to influence and gain collaboration from and respect of key stakeholders
• Flexible, capable of managing change and ambiguity
• Good/very good analytical capabilities combined with creative problem-solving skills and a sense of urgency
• Basic/Profound Project Management skills

Knowledge and Experience: 

• Great/Extensive experience in clinical logistics or related field within the biopharmaceutical industry Leadership experience
• Experience/Profound experience in clinical supply chain management incl. IMP and non- IMP or related field within the biopharmaceutical industry
• Basic/Good understanding of financial tasks such as budgeting, revenue recognition, PTC, invoicing
• Experience/Good Experience in Packaging, Labeling and Distribution of (Non-) IMP
• Multinational work experience
• Fluent in English

(Senior)

• Good Leadership experience

Education:

• Bachelor or Master Degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health- related discipline, international trade or logistics business or relevant work experience /degree.