CTS & IRT/RTSM Manager
Denmark
Job Type
Permanent. If necessary, this role can be considered remote, which means the employee will work remotely on an ongoing basis and will not have an assigned workspace at Sply designated location.
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.