The Division of Biostatistics seeks a 100% time Drug Manager (Researcher 4) for the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), which is funded by the National Institutes of Health (NIH), conducts large randomized trials and epidemiological studies on HIV, influenza, Ebola, and COVID-19. INSIGHT includes several hundred clinical sites in 35 countries. In addition to regulatory, data management and biostatistical responsibilities for the clinical research performed, the U of M serves as the legal sponsor for many of these trials, which have studied treatments, therapeutics, and vaccines.
The primary goal of the INSIGHT research is to reduce morbidity and mortality associated with infectious diseases. The trials and studies conducted have substantial public health impact. The U of MN INSIGHT group is primarily responsible for ensuring that funding sources are secured for the network research, that the research is managed in accordance with the terms and conditions of applicable federal grants and contracts, that the research is conducted in a timely and safe way, that the data collected are of the highest quality, that all regulatory requirements are adhered to, and that study results are widely disseminated. This work requires close collaboration with multiple national and international partners, including four International Coordinating Centers (ICCs) in Copenhagen, London, Sydney, and Washington. INSIGHT staff at U of MN must have a broad range of expertise to carry out this large-scale international research.
This position is responsible for management of study therapeutics in INSIGHT clinical trials. The drugs may be licensed or investigational agents that are given to clinical trial participants, either as novel therapeutics or standard of care, background therapy. This management will include oversight of drug distribution subcontractors, tracking and replenishment of drug inventories at subcontractor depots and clinical sites, ensuring that sufficient quantities of drug are available at sites accruing trial participants, preparing regulatory and study implementation documents, and communicating with INSIGHT ICCs.
These activities take place in an environment that can quickly change, requiring the incumbent to be flexible, capable of adjusting priorities, problem-solve, and engage in multiple tasks contemporaneously. The position requires excellent oral and written communication skills.
1) Manage Drug Distribution Subcontractor (10%).
• Prepare summary of study-related drug distribution tasks. • Review proposals from prospective subcontractors. • Assemble the budget and work scope for the subcontract. • Track spending and review subcontractor invoices. • Serve as principal point of contact for the subcontractor.
2) Support Implementation of Drug Distribution Infrastructure (25%).
• Review primary and secondary drug labeling. • Ensure that necessary regulatory documents are identified and collected. • Assist with plans for Quality Person release in the European Union. • Assist ICCs with actions to obtain import permits. • Ensure confidentiality of selected pharma documents. • Assist with plans to establish subcontractor and vendor depots for study drug. • Serve as principal point of contact for drug supplier(s).
3) Develop Study Pharmaceutical Documents and Capabilities (20%).
• Prepare Pharmacy Procedures. • Prepare Pharmacy Plan. • Coordinate site pharmacy approvals and site registration procedures. • Assist with clinical site pharmacy training • Assist with any drug-related INSIGHT website functions.
4) Track and Manage Study Drug Inventories (40%).
• Assist with development of a study drug tracking and inventory database. • Update the database to reflect replenishment of depot and clinical site drug inventories. • Update the database to reflect any transfers of drug between depots or clinical sites. • Facilitate and ensure that the drug distribution subcontractor has sufficient inventories at depots to supply sites. • Allocate drug to clinical sites in sufficient quantities to ensure that they can continue to randomize participants. • Place orders for clinical sites with the drug distribution subcontractor based on the allocations.
5) Miscellaneous Tasks (5%).
• Regularly participate in drug distribution planning and implementation telecons. • Facilitate drug shipments when the University is the Importer of Record. • Ensure proper notice to ICCs of drug recalls. • Prepare instructions at study closure for destruction or other disposition of remaining clinical site drug inventories.
The University of Minnesota offers a comprehensive benefits package including:
· Competitive wages, paid holidays, vacation and sick leave · Low cost medical, dental, and pharmacy plans · Health care and dependent daycare flexible spending accounts · Excellent retirement plans with employer match · Disability and employer paid life insurance · Wellbeing program with reduced insurance premiums · Tuition reimbursement opportunities covering 75%-100% of eligible tuition · Student loan forgiveness opportunity · Opportunities for growth and promotion · Employee Assistance Program
For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2020_tcd-cslr-75100-ben-0105-7_cs_final.pdf
Required Qualifications: Master’s degree and 2 years of related experience or BS/BA and 4 years of related experience.
Preferred Qualifications: Familiarity with clinical trials and/or pharmaceutical regulation is advantageous
Internal Number: 337540
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.