Description
The Manager, Clinical Supplies plans, establishes, manages and monitors activities related to clinical trial supply including budgets to support the drug development process (Phase I-IV), in cooperation with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements. Lead role in responsibility for supporting complex studies trial supply requiring project management, IxRS, distribution, and supply logistics such as packaging/labeling and transporting supplies globally. This position interacts with clinical study teams, Manufacturing, QA & Regulatory as well as distributors, labeling and packaging vendors.Principal Responsibilities:
- Leads the planning, generation and management of IMP supply project plans, based on study forecasts with Clinical project managers
- Accountable for the scheduling and timely delivery of packaged clinical trial material, including randomization and the packaging, labeling and international distribution of clinical supplies
- Evaluate, select, and implement contract manufacturing, packaging, and labeling operations
- Negotiate supply/technical agreements, oversee operations, and act as primary liaison between clinical personnel and contractor(s) on assigned projects
- Direct and monitor clinical supply contractor set up, progress and implements corrective actions when issues arise to support the clinical trial timeline
- Manages development and implementation of IxRS supply and drug return strategy with contractors and sites
- Manages Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed
- Creates metrics to gauge performance of clinical supply versus forecast
- Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials
- Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects
- Participates as SME for clinical regulatory audits related to supply
- Represents Clinical Supplies on global clinical project teams
Qualifications:
- BS/BA degree in related field preferred
- Minimum 7 years' experience of Supply Chain (Global Logistics, Packaging and Labeling) with responsibility of logistics and distribution with third parties
- Experience handling large and complex Phase II/III studies; oncology a plus
- Demonstrated ability to work in global supply chain management, maintain customer relations, lead as a change agent, handle multiple tasks simultaneously and negotiate and meet critical timelines
- Excellent oral and written communication is required to communicate with the team, peers, management and external contacts
- Excellent planning, organizational, analytical and management skills
- Strong attention to detail
- Proven decision making and negotiation skills and experience
- Proficient with interpreting cGCPs, cGDPs, Regulations and ANNEX 13 guidelines
- Proficiency with personal computers and Microsoft Office Products, including Word, Project, Power Point and Excel
- Import/export knowledge desirable.
To find out more about Real please visit www.realstaffing.com