Essential Function
The Clinical Logistics Leader ensures that clinical logistics projects are progressing and systems are set up and maintained according to quality standards, SOPs and applicable ICH-GxP* and other applicable industry guidelines.
According to departmental needs and personal capabilities CLL may also take over a variety of Clinical Logistics Services internal leadership tasks (e.g. achievement of target performance levels for team managed, review/development of controlled documents, global expansion/harmonization, business development tasks etc.)
Key Accountabilities
General:
• Proactively engages external and internal clients to improve solutions.
• Works towards establishing positive relationships with internal and external clients.
• Leads development of logistics concepts.
• Leading projects and teams, including set-up, conduct and closure phases.
• Provides project-related directions to interdepartmental team assigned to the project
• Provides clinical logistics training to the study team.
• Ensure ongoing training and career development to the team.
• Ensures study/project timelines, budgets and efficiencies are met.
• Leads development of required study documents and systems according to given project
• Controls and reports costs for internal service fees and external providers.
• Maintains PAREXEL internal project controlling/financial systems (e.g. TIME, PERFORM, PILA)
• Represents Clinical Logistics Services at client and internal project meetings.
• Complies with Quality standards, including applicable SOPs and GxP* standards.
• Travels as required by projects and Clinical Logistics Services activities.
• Uses a positive, objective, balanced, and result-driven approach.
At the request of the applicable Clinical Logistics Services Director or Manager:
• Actively takes part in the bidding process
(Proposal, 3rd Party Vendor Selection, Bid Defense, Contracts negotiation and review)
including client presentations.
• Represents PAREXEL at professional meetings/conferences as participant and/or speaker.
• Collaborate with quality team in development and maintenance of SOPs and working procedures.
• Develops reports and statistics for studies and department.
• Supports ongoing optimization of system infrastructure
(systems used by Clinical Logistics Services such as Warehouse Management System, LOMAS or
IPTrack, processes, PAREXEL internal tools).
Job specialization to be ticked by responsible Leader, based on professional focus:
Laboratory Services:
• Identifies, qualifies and leads laboratories for routine and esoteric analyses and courier services according to protocol requirements, subject to relevant Clinical Logistics Services Director¡¯s agreement and in collaboration with PAREXEL Procurement.
• Supervises study specific lab service concepts and solutions in close cooperation with laboratories and courier service providers.
• Performs or manages laboratory data management and reporting of lab results to sites in cooperation with Clinical Logistics Specialists.
• Performs or manages query management in cooperation with Clinical Logistics Specialists.
Clinical Trial Supply Services:
• Leads purchasing, manufacturing, distribution, return and destruction of medication for clinical trials, as applicable.
• Identifies, qualifies and leads pharmacies, pharmaceutical manufacturers, drug depots and courier services, subject to relevant Clinical Logistics Services Director¡¯s agreement and in collaboration with PAREXEL Procurement and Research Regulatory Compliance.
• Supervises development of documents including master labels for study medication, manuals and quality documentation.
• Supervises and tracks manufacturing processes and control GMP compliance.
• Supervises set-up and maintenance of inventory management systems e.g. IVRS.
• Supervises the label development and labeling process.
• Develops processes for temperature control for Clinical Trial Supplies and controls execution.
• Oversees central file and product specification file documentation.
• Organizes and supervises import / export and purchase of medication.
Ancillary Supplies Services :
• Incorporates the implications of local licensing and registration of medical devices for distribution
process and supply chain.
• Manages materials according to import, export, and transportation regulations.
• Leads purchasing, distribution, return and destruction of any ancillary supplies.
• Support Technical Logistics Leaders in development of specific technical solutions.
• Provides supply status reports to appropriate project team members.
Skills
• Ability to lead and build rapport with a culturally diverse group at multiple levels and disciplines.
• Credible team leader with good facilitation skills.
• Strong client focus.
• Demonstrated ability to conduct business in English (written and spoken) and in
local language if different from English.
• Very good understanding of the drug development regulatory framework
• 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.
• Very good competencies in leading and conduct of financial tasks such as budgeting,
revenue recognition, change in scope analysis, cost negotiations, and financial metrics analysis.
• Project Management skills.
• Ability to mentor, supervise, encourage, train and support team members
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.
Minimum Work Experience
• Very good Experience in clinical logistics or related field within the biopharmaceutical industry.
• Demonstrated team leadership experience.
• Experience in presenting at international conferences, meetings and trainings.
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