Clinical Trial Supply Pay: $50-$70 - I have flex on pay if needed 3 month contract, can get extended
This position supports Horizon and IIT clinical studies and is primarily responsible for clinical supply planning for new and ongoing studies to ensure availability of drug for patients, effective inventory management and a cost effective, compliant supply chain. This position will also support commercial supply planning, as needed. Responsibilities:
Qualifications and Skills Required:
- Manage clinical supply requirements in partnership with Clinical Operations and Manufacturing, as well as clinical packagers and depots. Ensure availability of drug for patient visits and in accordance with clinical site ordering patterns. Perform inventory reconciliations and timely destruction of obsolete/expired/returned product. Anticipate and proactively manage risks within the supply chain.
- Support the selection and qualification of clinical CMO's. Support clinical trial start-up and wind-down activities, clinical label/sku development, distribution protocols/SOP generation, as well as ongoing vendor management.
- Responsible for documentation research to support audits.
- Responsible for assuring accurate drug accountability/reconciliation for investigational medicinal product (IMP) issued during the study to the site and at the end of the study.
- Responsible for helping with set-up of all third party vendor specifications (i.e. IWRS) for distribution and reconciliation of clinical trial materials.
- Support the selection and qualification of shipping solutions for commercial and clinical products that are both cost effective and ensure product integrity. Drive continuous improvement and consolidation of vendors.
- Support short term and long term commercial forecasting, planning and production requirements, and any transition/integration activities, as needed. Lead/support project management for key initiatives.
Essential Core Competencies:
- Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field.
- Minimum 2-3 years (prefer 5 years or more) in bio/pharmaceutical industry, or combination of education and experience
- Experience in Clinical Trial Supply in virtual manufacturing, e.g. managing outsourced business partners including 3rd party manufacturing, packaging, warehousing & distribution
- Working knowledge of current GMP/GCP/GDP regulations
- Knowledge of clinical supply chain including packaging, blinding, randomization and IRT functionality
- Knowledge of commercial supply planning processes
- Excellent communication including strong interpersonal and written presentation skills
- Strong project management, people management and organizational skills.
- Strong computer skills, proficient in MS office and ERP systems, particularly SAP
- Strong quantitative and analytical skills
- Willingness and ability to travel internationally and domestically up to 5%-10%
- Ability to operate in an international, multicultural, multidisciplinary organization
- Action Oriented
- Problem Solving
- Functional/Technical Skills
- Priority Setting
- Drive for Results
- Strategic Agility
- Intellectual Horsepower
- Dealing with Ambiguity
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.