Job description Posted 13 April 2023


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?

Job Purpose

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.

Why you?

Basic Qualifications:

Bachelor's degree

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

Preferred Qualifications:

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