Clinical Supply Chain IRT Manager
The Company
A global biopharmaceutical company is seeking an experienced IRT specialist to join their Clinical Supply Systems team to support the company’s continued expansion in the EMEA, North American, and APAC regions.
Developing market disruption oncology medicines and auto-immune products, they are delivering life saving healthcare to millions of people around the world.
The role can be based remotely based in either Germany or the UK
Responsibilities
- Determines research supply parameters using information from the IMPM
- Arranges for the study parameters to be communicated to the IRT vendor.
- Oversees the configuration and upkeep of the IRT system (user acceptance testing, assessment of user requirements specifications).
- Writes and evaluates the script for the UAT test.
- Organises user acceptance testing and detects configuration risks
- Compiles input and arranges for the evaluation of hazards found during testing
- Uploads finished UAT testing and IRT User Requirement Specifications to eTMF
- Creates instructional materials for IRT
- Promotes performance management with the vendor, including debugging and KPIs.
- Primary point of contact for IRT vendor
- Assists and instructs people on how to use the IRT system.
Requirements
- Relevant professional experience (often more than three years) using IRT systems in clinical trials in the biotech, pharmaceutical, or other comparable industries
- Thorough understanding of IT-System Validation Activities
- Thorough knowledge of patient randomization techniques and their possible effects on healthcare supply optimisation and waste
- Thorough familiarity with IRT systems and familiarity with common office applications (e.g., MS Office)
- Considerable expertise in the use of IRT technologies to optimise the clinical supply chain across a variety of research designs and kinds.
- Working familiarity with the clinical supply chain and related GDPP / GMP activities
- Capacity to read, comprehend, and communicate clinical protocol requirements for IRT system needs
- Capacity to create training materials and deliver trainings
- Proficiency in Business and Professional English
To apply, email; [email protected]
NOTE : As much as we strive to consider as many applicants as possible, not everyone can be selected for an interview to discuss applications further.
Only relevant candidates can be selected for further consideration.
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