Main Tasks

Study Set up and maintenance (e.g., creating, amending study in IRT based on protocol design, amendments, helping answering Helpdesk, central and local study teams on complex IRT questions/study operational situations on a day-to-day basis) Supporting

Quality and processes (e.g., creating/updating SOP, guidelines, training materials, handbooks, delivering F2F IRT trainings to study stat, safety etc., responsible for all IRT related study documentation in eTMF from creation to archiving stage, regularization of legacy/non-documented processes)

Supporting Study team as overall SME for IRT tool, randomization, blinding/un-blinding (e.g., continuously supporting study statisticians, trial supply managers and other central functions from concept protocol design to logistical & supply strategy design to protocol amendment, study operational manual, providing inputs to quality incidents /CAPAs, FSO study setup, attending IT meetings as IRT business owner pushing on improvements, bug-fixes, informal testing etc.

Manage and lead interactions with: 

• Study statisticians
• Clinical Trial Supply Managers and Trial supply assistants
• Study Managers (Study Delivery Leads, Local Delivery Leads) and Study Monitors
• Clinical Research Development Leads/Medical Lead, Safety
• Helpdesk (sometimes can directly answer to study nurse, pharmacist for a complex question)
• Tech

Required skills, quailties and expected level:

• Independently configures and manages/maintains complex IRT study designs, possibly those with an international or more complex design, adaptive design, etc.
• Proactively identify and communicate issues as well as provide proposed solutions. Develop supply strategy to eliminate stock outs, minimize waste and reduce shipments. Assist with Helpdesk during daytime hours, when needed, in addition to participating on Helpdesk Stand-by/On-Call rotations (nights, weekends, and holidays).
• Responsible for drafting, amending, & determining gaps in SOPs.
• Accountable for identifying, owning, and implementing process improvements and training needs & gaps.
• Analyse data and drive/implement continuous improvements.
• Provide technical guidance/support to Clinical Development for their outsourced IRT studies.
• Lead interactions with RDIT for operational system issues and drive future IRT enhancements.
• Raise Deviations/Vendor Complaints/Customer Complaints and associated CAPAs.

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to support you in your continuous personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits ( pension and health insurance, …) based on your background and experience.

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 deliver 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.