KAMAL KAUR
Clinical Logistics Lead
Souderton,PA
Summary
Detail-oriented Project Lead with 5+ years of experience leading complex, cross-functional initiatives in clinical supply chain, global logistics, and regulated environments (GxP/GMP). Proven ability to manage end-to-end project lifecycles including planning, execution, risk mitigation, stakeholder communication, budgeting, and continuous improvement. Strong background working with global teams, vendors, and regulatory partners across 50+ countries.
Overview
2
2
Certifications
10
10
years of professional experience
Work History
International Logistics Specialist
Myonex
Horsham, PA
01.2026 - Current
- Manage end-to-end global clinical logistics operations supporting Phase I–IV clinical trials, ensuring uninterrupted investigational product supply and compliance with FDA, DEA, USDA, U.S. Customs, GDP, GCP, HIPAA, and global trade regulations.
- Lead DEA import/export permit applications for Schedule I–V controlled substances through the IMEX system, ensuring timely regulatory approvals and uninterrupted clinical supply.
- Serve as Importer of Record (IOR), overseeing HTS classification, customs documentation, FDA admissibility reviews, ITACS filings, customs clearance, and import/export compliance.
- Direct domestic and international distribution of investigational products, comparators, ancillary supplies, temperature-controlled, high-value, virtual, blinded virtual drop, and Direct-to-Patient (DTP) shipments using Oracle ERP.
- Partner with Clinical Operations, Project Management, Procurement, Quality, Warehousing, customs brokers, depots, and specialty logistics providers to execute complex global clinical supply strategies.
- Lead vendor governance meetings, monitor logistics KPIs, manage Vendor Non-Conformance (VNC) investigations, drive CAPA, and implement continuous process improvements to improve operational performance.
- Develop shipment trackers, KPI dashboards, SOPs, templates, and standardized workflows to enhance shipment visibility, operational efficiency, and regulatory compliance.
- Coordinate global return-for-destruction shipments, preparing Commercial Invoices, USDA Statements, End Use Letters (EUL), and other import/export documentation.
- Trained and mentored new employees within six months of joining, acting as a subject matter expert for clinical logistics, global trade compliance, and shipment execution.
- Manage multiple concurrent global clinical studies, proactively mitigating logistics risks, resolving critical shipment issues, and ensuring on-time study execution.
Distribution Planning Specialist
Merck Sharp & Dohme LLC (via Kelly Services)
West Point, PA
05.2024 - 10.2025
- Owned end-to-end project planning in SAP, including lead times, routing strategies, capacity planning, and cost analysis to support clinical trial milestones.
- Acted as Single Point of Contact (SPOC) for distribution strategy, coordinating stakeholders across 50+ countries and ensuring alignment with protocol timelines and FSR dates.
- Led global distribution projects for complex clinical trial protocols, managing scope, timelines, dependencies, and deliverables across planning, production, logistics, regulatory, and country operations teams.
- Developed and executed distribution network designs, including primary and alternate routes, to mitigate risks and support emergency shipments.
- Managed risk assessments related to customs clearance, trade compliance, temperature control, and material availability; implemented mitigation strategies to prevent delays.
- Oversaw vendor and courier coordination, approved quotes, tracked KPIs, and ensured adherence to budget and service-level agreements.
- Drove change management activities including re-siting studies, onboarding new depots, and updating plans due to protocol or regulatory changes.
- Provided regular status updates, dashboards, and reports to leadership and external partners.
Clinical Logistics Project Coordinator
Almac Group
Souderton, PA
11.2021 - 04.2024
- Analyzed daily distribution activities with distribution management, modifying processes to enhance quality and efficiency.
- Processed all DTP/ATP and bulk shipment requests related to various clinical studies; ensured the processes aligned in accordance with GMP, applicable ICH-GxP and all relevant Almac Clinical Services SOPs.
- Led issue management and CAPA coordination for shipment delays, temperature excursions, and courier deviations.
- Managed shipment schedules, tracked progress, and resolved issues to maintain uninterrupted trial support.
- Led issue management and CAPA coordination for shipment delays and temperature excursions, ensuring compliance and timely resolutions.
- Supported project cost estimation and quoting, working with project managers and customers to align logistics scope and budget and all relevant Almac Clinical Services SOP’s.
Administrative Assistant (Operations Support)
Stella Jones (via Express Employment)
Plymouth Meeting, PA
07.2021 - 10.2021
- Managed product inventory and submitted invoices daily using Blue Bee application, ensuring up-to-date records.
- Supported operational projects by maintaining inventory systems, optimizing delivery routes, and coordinating with dispatch and third-party vendors.
- Assisted with schedule management, reporting, and documentation, contributing to improved delivery accuracy and operational transparency.
- Optimized delivery routes and logged daily driver manifest data, coordinating with dispatch team to resolve discrepancies and maintain mileage log for fleet vehicles.
- Collaborated with dispatch, accounting, and third-party carriers to ensure accuracy of paperwork and adherence to billing processes.
Administrative Coordinator/Office Manager
Princeton Selling Group
Wayne, PA
05.2016 - 05.2017
- Created and managed title information for global publishers, conducting periodic audits to ensure accuracy.
- Managed internal projects related to data migration, customer communications, and sales enablement initiatives.
- Developed electronic mailings to increase sales by creating newsletters, performing data mining and drafting a list of target audience.
- Distributed title information to customers such as Amazon.com, BarnesandNoble.com etc. thereby increasing sales.
- Coordinated timelines and stakeholder communications for marketing and publishing partners, ensuring timely delivery of project deliverables.
Education
Post Graduate Diploma - Business Administration
Sikkim Manipal University
IndiaBachelors in B.A. Honors - English
Delhi University
IndiaDiploma - Advertising, Marketing and Public Relation
Polytechnic for Women
IndiaDiploma - Multimedia and Animation
Arena Multimedia
IndiaSkills
- Project Planning & Execution
- Route optimization strategies
- Time management
- Shipping and receiving operations
- Supply chain management
- Cross-Functional Stakeholder Management
Accomplishments
- Recognized globally by Myonex leadership within six months of joining for outstanding contributions to global clinical logistics operations and continuous improvement initiatives.
- Featured in Myonex global employee recognition program and on the Horsham site recognition display.
- Selected to train and onboard new employees within six months, serving as a subject matter expert for clinical logistics execution,regulatory compliance and global transportation operations.
Certification
APICS Certified Supply Chain Professional (CSCP) - In Progress
Timeline
International Logistics Specialist
Myonex
01.2026 - Current
Distribution Planning Specialist
Merck Sharp & Dohme LLC (via Kelly Services)
05.2024 - 10.2025
Clinical Logistics Project Coordinator
Almac Group
11.2021 - 04.2024
Administrative Assistant (Operations Support)
Stella Jones (via Express Employment)
07.2021 - 10.2021
Administrative Coordinator/Office Manager
Princeton Selling Group
05.2016 - 05.2017
Diploma - Multimedia and Animation
Arena Multimedia
Diploma - Advertising, Marketing and Public Relation
Polytechnic for Women
Bachelors in B.A. Honors - English
Delhi University
Post Graduate Diploma - Business Administration
Sikkim Manipal University
SYSTEMS
Oracle | SAP | Cosmos |QLIK | Sales Force | BlueBee | Veeva Vault | ZenQMS | TrackWise | Ennov | Workbench | IMEX (DEA) | Smartsheet | ADP Workforce Now | Microsoft Office