Manager, Clinical Packaging & Supplies
Job Locations Belgium-Leuven Category Clinical Operations
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
Headquartered in Cincinnati, Ohio, employing approximately 3,500 people across almost 40 countries.
We are seeking a Manager, Clinical Packaging and Supplies to organize and execute activities involved with the management of investigational product and associated ancillary supplies in support of clinical studies.
Are you interested in delivering effective, end-to-end collaboration, and training around the globe to accelerate the global development of safe and effective medical therapeutics?
If so, this opportunity is for you.
Development and management of timelines associated with the delivery of Investigational Product;
Management of packaging, labeling, storage, and distribution of Investigational Product;
Procurement and distribution of ancillary supplies, comparative agents, and / or protocol driven baseline therapies;
Forecasting / projecting Investigational Product and ancillary supplies to meet country approval, depot set up, site initiation, and patient enrollment;
Proactively perform and manage risk associated with timeline changes, addition or deletion of depots, countries, sites, and enrollment variances;
Proactively account for, and manage, expected overages and unexpected losses;
Proactively manage and perform risk assessment of use-by date of Investigational Product and supplies, along with need for Just in Time labeling, date extension labeling, and / or product resupply;
Collaborate with IRT, Sponsor, and clinical study team to develop IRT specifications, perform User testing, as may be necessary to support site initiation, site resupply, patient dosing;
Directly or indirectly manage third party packaging, labeling, storage, distribution vendors and international depots;
Design and / or review of labels to meet product requirements and ensure compliance with US and international regulations; and
Timeline development with associated proactive risk identification, mitigation, and management.
Bachelor’s degree in Pharmacy or related field (MS, Pharm D preferred, with education or experience as potential reciprocal substitutes);
Minimum 5 to 10 years direct experience in clinical supply management from start-up to close-out, including planning, labeling, packaging, release, storage, distribution, reconciliation, returns, and destruction;
Knowledge of pharmaceutical stability protocols;
Knowledge of GMP batch record development, review, approval, and release processes;
Demonstrated knowledge and application of FDA, DEA, Customs / Import, and DOT standards and regulations;
Knowledge of GCP and global cGMP regulations, including QP release;
Demonstrated knowledge of warehousing, distribution, and logistics (including cold chain distribution);
Multi-therapeutic experience across varied product presentations and storage conditions;
Excellent project management and communication skills;
Flexibility and confidence to work in at-risk and changing environment, for multiple concurrent clinical studies;
Ability to interact and persuade by influence internally with Medpace and externally with Sponsor, across all levels of the both organizations; and
Staying current on industry trends.