Are you looking to broaden your understanding of how clinical trials are executed? Would you like to learn more about study designs and delivering investigational product to patients?
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. Individual is responsible for ensuring data integrity is maintained and driving /implementing continuous improvement across all Clinical Supplies systems. Individual is responsible for oversight of Clinical Studies by non-GSK IRT Vendors.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Assess planned studies for suitability for RAMOS IRT system.
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.
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.
3-5 years experience in IRT or clinical supplies
To be successful in this role, you should possess:
Basic understanding of clinical Trials and clinical supplies
Demonstrates fundamental 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
Should be 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
Must exhibit excellent oral and written communication skills
Good interpersonal skills
Good planning and coordination skills
Creative and innovative thinking
Strong problem-solving skills
5-7 years experience working with IRT systems.
Basic understanding of clinical trial design
Ability to interpret study protocols and understand the impact on IRT design and supply of medicines to patients