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The job details are as follows:The Clinical Supply Chain Manager, Strategic Development will manage the manufacture, supply, availability, budgeting and delivery of Clinical Trial Material to support all Strategic Development preclinical and clinical trials. This role will facilitate processes to help assure uninterrupted clinical trial material supply.
- Forecast, track, and manage Clinical Trial Material manufacturing and supply chain including raw materials coordination, manufacturing operations packaging and labeling
- Attend and participate in study-related meetings to build cross-functional relationships, gather information on study progress and share information on CTM status
- Maintain oversight of CTM study files (hard copy & electronic, as appropriate) to ensure they are kept current, accurate, and complete in the TMF
- Maintain accurate clinical supply inventory and disposition documentation
- Coordinate distribution of clinical supplies to approved investigational sites
- Collaborate with Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery
- Coordinate with CMC and Quality Assurance (QA) partners to manage technical and quality issues to facilitate uninterrupted supplies
- Manage and oversee Clinical Trial Material Vendors at a high level
- Interface with QA and CMC groups to support release of clinical supplies material and ensure regulatory submissions are up to date
- Ensure uninterrupted supplies throughout the duration of clinical studies
- Management oversight of the development of processes, procedures, and guidelines to meet short and long-term goals for clinical supplies, including pharmacy manual and SOP creation/maintenance when required
- Provide high-level feedback on the development and implementation of IVRS/IWRS systems
- Create, coordinate labeling activities at RTP and CMOs e and maintain clinical labels and IFUs for the clinic
- Prepare presentations for Investigator Meetings, CRA training, site initiations or other similar training situations
- Manage outsourcing activities with various contract vendors to develop project contract, packaging plans, batch records, and distribution strategies for outsourced projects
- Assist with clinical audits for all Strategic Development related projects
- Attend onsite dosing sessions to assist with training
- Coordinate with marketing to help develop final labeling materials for commercial product
- Perform other duties as assigned
Minimum Requirements
- Bachelor's Degree in a scientific or technical related field
- 8+ years of experience in the pharmaceutical/clinical research industry with a Bachelor's Degree, or
- 6+ years of experience in the pharmaceutical/clinical research industry with a Master's Degree
- 3+ years of relevant clinical supply chain management/work experience
- Experience managing and overseeing Clinical Trial Material Vendors
- Experience with IVRS/IWRS systems required (developing and implementing IVRS/IWRS systems preferred)
- Ability to prioritize, organize and manage multiple projects simultaneously
- Working knowledge of GCP and GMP environments and requirements
- Familiarity with clinical trial packaging/labeling and/or distribution
- Strong customer service and cross-functional interpersonal skills
- Working knowledge of clinical trials and the drug development process
- Ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and recommends possible solutions to the problem
- Ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals; The ability to handle many conflicting priorities is critical to build and maintain credibility and respect across the many different constituents in the supply chain
- Strong proficiency in MS Office suite, including Word, Excel, and PowerPoint
- Excellent oral and written communication
Preferred Qualifications
- Master's Degree in a scientific or technical related field
- Project Management experience
- Ability to give professional and concise presentations at internal and external meetings
Job Location
This role is based in our Durham, NC office. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
