The randomisation officer is supporting her/his customers on all randomisation and blinding related topics.
(S)he will be working mainly on the below tasks (for which technical and process expertise are needed):
SBIR (GSK Randomisation System) operational actions; e.g.:
- Study set-up
- Study maintenance (requests from and outside GSK)
- Peer reviews,
- Warnings management
- eTMF QC and archiving
Documentation management; e.g.:
- Specifications/validations of scripts (linked to SBIR or not),
- Periodic reviews of SOPs and working instructions (some have to be created),
- Process guidelines writing/updating,
- Training supports maintenance/improvements (specific certificates included),
Randomisation and (un-)blinding expert (MatEx tool included); e.g.:
- Concept protocol/protocol review,
- LR&KO meeting,
Any other action/support related to randomisation and (un-)blinding
- Bachelor’s or master’s degree or equivalent in Engineering, Life Sciences, Computer Sciences, Mathematics and/or Physics.
- Minimum 3 years’ professional experience in Pharma / Clinical trials environment
- ORACLE SQL and data flow skills (PL/SQL is a plus)
- Able to ensure a high degree of reliability, to look for details, cautious but flexible, logical mind, and demonstrate communication skills
- Strong understanding of documentation management (writing, improving): users’ guides, standard documents, trainings’ supports, programs’ specifications and validations, archiving, …
- Able to work frequently under pressure, both independently and as part of a team, and fit into a multicultural working environment
- Fluent in English (French and other languages are a plus)
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 - Waterloo
- Nijverheidslaan 3, - Strombeek Bever