Clinical Trial Supply
About the Role
In this role, the CTS & IRT Manager coordinates the operational aspects of clinical supply for assigned clinical trials. The clinical supply manager will be required to manage pack/label, global distribution, and IRT/RTMS systems.
Responsibilities:
- Oversees and coordinates all operational aspects of assigned sponsor-driven clinical trial supply activities.
- Ensures that appropriate trial timelines are met for a clinical supply and financial perspective.
- Is responsible for addressing issues with clinical supply deliverables, as necessary.
- Assumes control of all communication between clinical trial team and CMO as it relates to pack, label, storage, and logistics.
- Maintains a working knowledge of present GxP guidelines and clinical supply standards.
- Works closely with the Sply staff.
- Communicates daily with the Sply team.
- Perform IRT/RTSM User Acceptance Testing on behalf of sponsors
- Attends industry events as it relates to clinical trial supply and IRT/RTSM systems.
- Assist in development and implementation of new procedures and technologies for clinical supply and IRT/RTSM systems.
Preferred Education:
- Bachelor's degree or Master degree in Pharmacy, biology, medicine or supply chain management.
Additonal information:
- A competitive salary package is offered, which factors in various geographic regions. The pay offered will take into account job-related knowledge, skilles, and experience among other factors.
Requirements
Minimum of 2 years of related operational supply planning, medication management. Procurement experience and GMP knowledge is a plus.
Must have strong interpersonal skilles, including voice and email communication, and negotiating skills
Has awareness of eClinical technology and procedures
About the Company
Sply is a specialized clinical trial supply vendor with the following business segments: clinical trial supply operations, IRT/RTSM setup and UAT, Supply forecasting, and CTS consulting. Sply operates out of Denmark and our employees work together to offer best-in-class clinical supply deliverables.