Senior Clinical Supply Consultant

Product Life Group (PLG), an international Consulting group is seeking a fully remote Senior Clinical Supply Consultant , to serve as the unblinded clinical supply lead for our client’s blinded clinical program. This role will provide strategic and direct leadership of the clinical supply chain, including demand planning and forecasting, IRT system development and management, and the authoring of supporting SOPs, while safeguarding study blind integrity throughout the life of the program. Role and Responsibilities Serve as the unblinded clinical supply representative for blinded studies, maintaining strict separation of unblinded information and safeguarding study blind integrity in accordance with the protocol, ICH E6 GCP, and applicable SOPs, Manage randomization and kit list information, unblinded supply documentation, and access controls in coordination with Biostatistics and the IRT vendor, Provide clinical supply and blinding plan input to the protocol, IRB submissions, and informed consent, including who is blinded, how allocation concealment operates, and how emergency unblinding will occur, Compile a list of qualified contract packagers and aid in the selection of a contract packager, including RFP preparation, capability assessments, bid review, and recommendations, Ensure investigational product is manufactured, packaged, and labeled under CGMP (21 CFR Parts 210 and 211, and FDA guidance on CGMP for Phase 1 investigational drugs), Interpret clinical study protocols as they apply to CTM demand, and develop supply plans and forecasts for API, bulk, and packaged drug product, Create, maintain, and manage production and packaging schedules aligned with enrollment projections and study milestones, Lead development and management of the IRT system, including vendor selection, user requirements specification, supply strategy, and resupply parameters, UAT, implementation, and ongoing maintenance, Configure IRT role-based user access controls and system reports to separate unblinded and blinded personnel and prevent inadvertent unblinding, and ensure the system is validated and compliant with 21 CFR Part 11, Establish and maintain secure emergency unblinding (code break) procedures through IRT or approved backup methods, ensuring rapid investigator access when clinically necessary, Design blinded forecasting and resupply strategies using site and depot trigger levels and automated kit assignment, so that shipments do not reveal whether actives or placebo are being sent, and monitor patient level supply as enrollment evolves, Manage domestic and international shipments of raw materials, comparators, and finished goods, including depot setup and temperature-controlled distribution, Manage CTM expiration and expiration date extension activities, including blinded relabeling, Maintain drug accountability, chain of custody, reconciliation, return, and destruction records in support of sponsor and investigator obligations under 21 CFR 312.57, 312.59, and 312.62, Support unblinded Data Monitoring Committee (DMC) activities as needed while preserving the blind of the sponsor study team and sites, Author and maintain appropriate SOPs covering clinical supply processes, unblinded activities, IRT management, emergency unblinding, and contract packager oversight, Maintain relationships and negotiate contracts with suppliers, contract packagers, depots, and IRT vendors, Qualifications and Education Requirements Bachelor’s or advanced degree in Pharmacy, Chemistry, Life Sciences, Supply Chain Management, or related discipline, or equivalent combination of education, training, and experience, Experience (10+ years) in clinical supply chain management, including direct experience serving in an unblinded clinical supply role on blinded studies, Direct experience with IRT (IVRS/IWRS) design, specification, UAT, and supply management, Proven ability to author SOPs and work within GMP and GCP quality systems, Knowledge of cGMPs, ICH E6 GCP, FDA…

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