Highlights
You will focus on day-to-day operational execution activities for assigned protocols, working closely with cross-functional teams including Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors. In this position, you will be responsible for the reliable and compliant execution of clinical supply across multiple protocols, ensuring materials are delivered to sites and patients on time.
Numbers & Facts
| Location | Cambridge, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $48.38 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Top 3 Must-Have Skills:
Overview
Key Responsibilities
- CMO experience (Contract Manufacturing Organizations), preferably within clinical supply chain operations.
- Hands-on experience with IRT systems.
- Strong critical thinking and problem-solving skills.
- End-to-end clinical supply chain knowledge.
Overview
- We are seeking an individual for the role of Specialist, Clinical Supply Chain - Operations. In this position, you will be responsible for the reliable and compliant execution of clinical supply across multiple protocols, ensuring materials are delivered to sites and patients on time. You will focus on day-to-day operational execution activities for assigned protocols, working closely with cross-functional teams including Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors. You will contribute to ensuring uninterrupted supply, managing execution activities, and maintaining visibility to supply status in a dynamic clinical trial environment.
Key Responsibilities
- Lead end-to-end execution of clinical supply activities including packaging, labeling, distribution, inventory management, and study closeout
- Execute supply activities aligned to protocol timelines (e.G., site readiness, patient supply, resupply management)
- Maintain visibility to inventory levels and supply availability across assigned studies
- Partner with Clinical Operations, QA, and vendors to execute clinical supply plans
- Support management of IRT systems including system use for supply tracking and resupply execution
- Identify and escalate execution risks such as delays, supply constraints, or deviations
- Support investigation and documentation of temperature excursions and supply deviations
- Ensure execution activities are compliant, appropriately documented, and inspection-ready
- Contribute to process improvements and support adoption of tools and ways of working
- Maintain accurate documentation including supply plans, trackers, and required clinical supply
- BS degree in Life Sciences or Supply Chain Management
- Experience: 3+ years of relevant experience
- Confident Understanding of end to end clinical supply chain activity
- Experience with IRT systems
- Experience with CMOs
- Strong understanding of GxP
- Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)
- Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics
- Strong attention to detail
- Excellent communication and collaboration skills across multiple stakeholders
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.