If you're ready to take your career to the next level, make a significant impact in clinical research, and be part of a dynamic and collaborative team, we encourage you to apply!
Keyrus Life Science is looking for a IRT Project Manager to join our consulting team for a client project based in Canada.
As an IRT Project Manager, you will be responsible for the design, development, testing, validation, execution, & maintenance of clinical studies in the RAMOS Interactive Response Technology (IRT) system
These will be your responsibilities:
Ensuring data integrity is maintained and driving /implementing continuous improvement across all Clinical Supplies systems.
- Responsible for oversight of Clinical Studies by non-GSK IRT Vendors.
- Assess planned studies for suitability for RAMOS IRT system.
- Independently configures and manages/maintains complex IRT study designs, possibly those with aninternational or more complex design, adaptive design, etc.
- Proactively identify and communicate issues as well as provide proposed solutions.
- May be IRT group business point of contact for technical systems (Randomization and Container Code,Packaging, and Shipping Systems).
- Responsible for drafting, amending, & determining gaps in SOPs.
- Raise Deviations/Customer Complaints and associated CAPAs. Assist with Helpdesk during daytime hours,when needed, in addition to participating on Helpdesk Stand-by/On-Call rotations (nights, weekends,holidays).
- Accountable for identifying, owning, and implementing process improvements and training needs & gaps.
- Analyze 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.
- Develop supply strategy to eliminate stockouts, minimize waste and reduce shipments.
Profile / Education
Bachelors degree or equivalent experience
Basic understanding of clinical Trials and clinical supplies
Knowledge of PDS - CSC computer systems.
Ability to maintain accurate records and files in accordance with GSK policy, cGMPs, and SOPs
Proven computing skills & experience with various software: Excel, Word, Powerpoint, Visio, MS Project, etc.
Proven ability to work in a matrix team
Ability to work independently
Detail-oriented and possess the ability to handle multiple tasks
Ability to train others inside and outside the workgroup in area of expertise
Experience in working with customer relations
Excellent oral and written communication skills in English
Good interpersonal skills
Good planning and coordination skills
Creative and innovative thinking
Strong problem-solving skills.
3-5 years experience in IRT or clinical supplies
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.