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 regulations (21 CFR Parts 11, 50, 56, 210, 211, and 312), and EU CTR requirements for investigational medicinal products essential.
Preferred Skills
Familiarity with production forecasts, forecast models, and clinical supply simulation tools,
Experience with complex study designs including double dummy, titration, and adaptive studies,
Experience with comparator sourcing and blinding strategies such as over-encapsulation,
Global clinical supply experience (US, EU, Asia, and ROW),
Demonstrated ability to establish strong vendor relationships on behalf of clients,
Ability to travel up to 20% as required.
Additional Notes
This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs. Consultants retain full autonomy to accept or decline project engagements at their discretion,
The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. PLG reserves the right to amend this description as client program needs evolve,
All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

Work arrangement
Yes