Manager, Clinical Supplies – Medpace – Cincinnati, OH, USA
We are seeking a Manager, Clinical Supplies to organize and execute activities involved with the management of investigational product and associated supplies in support of clinical studies. This position will be an integral part of the Medpace clinical operations team. The manager will be responsible for the activities below.
DESCRIPTION OF JOB DUTIES
- Development and management of timelines associated with the delivery of Investigational Product;
- Management of packaging, labeling, storage and distribution of Investigational Product;
- Procurement of comparative agents, and/or protocol driven baseline therapies;
- Forecasting/projecting volume of supplies required and manage variance in projections with patient enrollment shifts/changes, working closely with IVR team;
- Manage third party packaging vendors and international depots;
- Design and/or review of labels to meet product requirements and ensure compliance with US and international regulations;
- Assess and evaluate new projects; provide technical support for the development of new project proposals; and
- Participate in client visits, on-site and off-site, to represent drug product capabilities and expertise.
- Bachelor’s degree in Pharmacy or related field (MS, Pharm D preferred);
- Minimum 5 years direct experience in clinical supply management;
- Demonstrated experience with clinical supply management planning, labeling, packaging and distribution;
- Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products;
- Knowledge of GMP batch record development, review, and approval processes;
- Demonstrated knowledge and application of FDA, DEA, Customs/Import, and DOT standards and regulations;
- Knowledge of GCP and global cGMP regulations, (Knowledge of EU GMP QP regulations is preferred).
- Demonstrated knowledge of warehousing, distribution (including cold chain distribution), and logistics.
- Excellent project management and communication skills.
TRAVEL: approximately 20%