Manager, Clinical Supply
The Manager, Clinical Supply Management will primarily be responsible for the strategic management of secondary packaging, labeling and distribution for Investigational Product (IP) and/or ancillary supplies used in clinical trials. This individual will lead and assist with all domestic and international logistics and clinical supply activities related to company sponsored trials. The Manager will play an integral role in the development and management of the Interactive Response Technology (IRT) used to manage IP supply levels, shipments, and temperature excursions. The individual will also be responsible for reviewing, writing and revising Standard Operating Procedures (SOPs) and Work Instructions (WIs) that govern management of clinical trial supply distribution and temperature excursions.
* Collaboration with external vendors (e.g. IRT vendors, Clinical Research Organizations, Clinical Manufacturing Organizations) and internal functions (e.g. Project Management, Clinical Operations, Clinical Development, Quality Assurance, CMC) to ensure the timely packaging, labeling, and distribution of investigational product for company sponsored trials, Investigator Initiated Trials, and Expanded Access Programs
* Review and approval of batch records, specifications, deviations, investigations and other relevant cGMP documentation related to packaging and labeling of investigational clinical trial supply
* Develop investigational supply forecasts and strategic plans for on-time delivery
* Participate in proposal development process with clinical service vendors and CROs
* Participate on clinical sub-teams
* Resolve issues associated with creation, packaging, labeling and distribution of IP
* Prepare new and revise current SOPs and WIs that govern the management of clinical trial supply distribution and temperature excursions.
* Develop and maintain systems and processes to perform duties required to complete studies and projects in a timely manner, within budget, and of the quality required to meet organizational goals
* Strong knowledge of domestic and international clinical supplies/logistics
* Excellent teamwork and collaboration skills
* Effective process and management skills
* Performs administrative functions and additional tasks as requested.
* Proactively identify risks and plan for mitigation strategies
* Strong organization skills and the flexibility to react rapidly to changing situations
* Possess excellent written and verbal communication skills, including being able to effectively present information and respond to questions from project teams and external vendors
Experience / Skills:
* BA/BS degree or higher, preferably in the life sciences
* Must have at least 3 years of experience in clinical trials supply management
* Must have at least 5 years of experience working in a Pharmaceutical/Biotech/R&D environment
* Knowledge of global clinical trials supply management process
* Knowledge of cGCP, cGMP, ICH, FDA and EMEA regulatory requirements
* Detail-oriented with a high degree of organizational skills and ability to handle confidential materials
* Able to accomplish work independently and as part of a team
* Team player as demonstrated by good communication/collaboration skills
* Strong interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive
* Positive attitude and ability to establish and maintain positive working relationships
* Ability to manage deadlines and deliver on time with high quality output
* Strong project management, analytical and problem solving skills
* Experience with the Microsoft Office suite (i.e., Word, Visio, Excel, PowerPoint, etc.) and Adobe.
Sthree US is acting as an Employment Business in relation to this vacancy.