Key responsibilities of the position include converting Clinical demand into supply requirements for Clinical trials. Communicating Clinical demand to supporting manufacturing groups.

This position is also responsible for the tactical management of the day- to-day packaging, labeling and distribution activities for global clinical trials to achieve planned start dates and study milestones. Support Clinical Programs by managing demand requirements and converting into a long range supply plan. Communicate supply needs to adjacent production groups. Maintain supply/demand tools on a regular basis and communicate status to stakeholders. Support day to day management of Clinical Programs by establishing IVRS specifications for re-supply and inventory management.

Document and resolve temperature excursions and coordinate shipping qualification studies. Establish import/export documentation and requirements for individual countries. Mange re-supply activities for drug and ancillary supplies. Manage day to day logistical issues for clinical studies and manage return and reconciliation of clinical supplies from clinical sites. Assist in the investigation, resolution and corrective actions for non-conformances. Organize workload to provide proper task execution and adherence to timelines. Familiarity with related standard operating procedures (SOP’s) and specifications.

EXPERIENCE:
Experience working in a GMP/GCP environment.

Strong communication and team skills. Working in a matrixed environment.

Exceptional planning and organizational skills. Broad based computer knowledge including word and spreadsheet programs, and project management programs.

Additional acquisition and use of established document control and shipping software. Approve SOP’s, technical documents, and non-conformances.

SAP experience helpful.

EDUCATION:
B.A. or B.S. degree with 4-6 years experience in clinical supply distribution.

Please forward resumes to debbie.wilmer@discoverysolutions.net or call 443-402-1585