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Senior Clinical Supply Chain Consultant
Dark Horse Consulting Group. Act as supply chain lead, embedded Senior Manager of Clinical Supply Chain, on clients’ clinical study teams .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical supply chain management, including IRT/RTSM management, inventory strategies, and regulatory compliance across multiple regions. Proven ability to lead cross-functional teams and develop effective supply chain strategies for clinical trials.
Highest-signal resume keywords
Clinical Supply Chain ManagementIRT/RTSM ManagementRegulatory ComplianceDemand and Supply ModelsConsulting Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Supply ActivitiesPack and Label SchedulingInventory ManagementCold-Chain Biologics PackagingLabel Design and PackagingStudy Start-Up ActivitiesStudy Close-Out ActivitiesProcess Gap IdentificationSOP DevelopmentFinancial Information Assessment
Soft Skills
Client Stakeholder ManagementMentoring Junior StaffCross-Functional CollaborationPresentation SkillsProblem-Solving
Tools & Technologies
ExcelPowerPointIRT SystemsETMF SystemsCMO Partner Management
Certifications & Qualifications
CPIMCSCPSix Sigma Certification
Industry Keywords
CGMPGCPGDPBiopharmaceutical IndustryGlobal TrialsRegulatory EnvironmentsFDAEMAMHRAClinical Supply Chain Strategy
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Act as supply chain lead, embedded Senior Manager of Clinical Supply Chain, on clients’ clinical study teams
- Work cross-functionally with Clinical Operations, Quality, Regulatory, and CMC teams
- Manage clients’ cGMP, GCP, and GDP clinical trial supply activities, including pack and label scheduling, depot distribution, inventory management, IRT management, and protocol interpretation
- Lead selection of pack and label, IRT/RTSM, comparator, and ancillary-supply partners
- Lead CD&OP, SIOP, S&OP, and IBP cross-functional planning processes
- Create long-term CMC supply plans and short-term labeling and distribution schedules, including expiry management and over-labeling
- Create inventory management strategies for clinical sites and depots
- Identify process gaps and participate in writing SOPs and developing best practices
- Perform study start-up activities, including IRT/RTSM UAT, country and site activation, depot setup, and initial site supply
- Perform study close-out activities, including investigational product reconciliation, returns, and destruction
- Manage IRT/RTSM builds, including protocol requirements, user requirements specifications, UAT scripts and testing, and system changes
- Develop work plans with the engagement director, oversee execution, and report progress to client and internal stakeholders
- Assess client business processes, operational performance, supply chain structures, and financial information
- Advise senior client management on clinical supply chain strategy
- Serve as day-to-day client stakeholder contact and mentor junior consulting staff
- Participate in developing and presenting client deliverables
- Perform secondary research and analysis on industry trends and practices
- Contribute to Sales, Marketing, and Business Development initiatives, including proposal development and scoping conversations
Requirements
What you’ll need- 7+ years’ experience in clinical supply chain management in the biopharmaceutical industry
- Experience managing complex global trials and designing labeling and global supply chain strategies
- Experience supplying clinical trial materials to the US, Canada, UK, EU, LatAm, APAC, MENA
- Experience planning and coordinating label design and packaging activities with third-party CMO partners
- Experience utilizing and maintaining IRT for the supply chain role; experience with 4G a plus
- Experience creating and managing demand and supply models for clinical trials
- Experience selecting and onboarding partners to support packaging and/or IRT/RTSM
- Experience with cold-chain biologics and cell & gene therapy packaging
- Inspection readiness and eTMF filing experience
- Familiarity with multiple medical regulatory environments (FDA, EMA, MHRA) and compliance is essential
- Previous consulting experience is required
- Demonstrated experience leading workstreams or small teams in a client-facing or consulting environment
- Strong Excel and PowerPoint skills required
- CPIM, CSCP, or Six Sigma certification a plus
- Relevant undergraduate degree, with MBA or other advanced degree, or equivalent experience
Benefits
Comp & perks- Competitive compensation, commensurate with experience
- Flexible, remote-first working environment