TheAssociate Director, ClinicalTrial Material, will beresponsible for the development and implementation ofclinical trial material (CTM) plans based on the clinical study protocols for global clinical studies ranging from phase1 –3 and any post approval drug clinical studies, Supply chain strategies and day-to day managing of critical supply chain activities across clinical projects, such as supply chain set up for new products and management of inventories, development of packaging and labeling design based on clinical study needs, Coordination and oversee all manufacturing and/or packaging atcontract manufacturing facilities, and Set-up of the IWRS for thedistribution andinventory management of ClinicalTrialMaterial (CTM).
- Serve as a subject matter expert on clinical trial material operations related issues by communicating proactively with the Senior Director, Pharmaceutical Development and Supply Chain.
- Serve as a subject matter expert on regulatory operations related issues by communicating proactively and effectively with the VP Global Regulatory Affairs and Quality Assurance.
- Ensure the Clinical trial material for all on-going and planned clinical studies is readily available.
- Provide guidance to R&D Teams on the options for the optimum packaging design, distribution plans, cost effective solutions.
- Create and manage clinical trial material (CTM) from design of package/label/distribution, forecasts, supply plans, inventory monitoring and budgets management of CTM.
- ClinicaltrialMaterial Supply chain management
- Order bulk drug product and packaging and labeling components
- Reveiw/approval of master and executed batch records for packaging, labeling, shipping and distribution
- Work with distributors, 3rd party logistic companies and customs to secure timely delivery of products
- Perform CTM inventory reconciliation
- Knowledgeable of IWRS System
- Setup of IWRS system for startup of all studies
- Manage inventory, shipments and all supplies within IWRS
- Must have knowledge of clinical supplies packaging process and technical aspects of packaging processes.
- Contact vendors and gain knowledge on their capabilities.
- Identify appropriate Contract Manufacturing Organizations and storage facilities for manufacturing, packaging and distribution of US and international clinical studies.
- Generate requests for proposals.
- Prepare project plans and budgets.
- Organize and maintain CTM documentation.
- Collaborate with clinical, quality and regulatory teams to ensure approval of all documents required for manufacturing, packaging, labeling, distribution and accountability of clinical trial materials.
- Represent Pharmaceutical Development Team at Project meetings.
- Develop junior team members.
- BA or BS degree in life science or equivalent.
- At least 10 years experience with management of clinical trial material for global clinical trials.
- Ability to manage multiple projects at the same time.
- Posses good technical and problem solving skills.
- Knowledgeable with GMP requirements for pharmaceutical packaging/labeling/distribution process and any related regulatory requirements.