Senior IRT Specialist
- Stevenage, United Kingdom
Site Name: UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence
Posted Date: Apr 15 2020
Are you interested in a role that manages and maintains the setup of Interactive Response Technologies to support study protocols in our Product Development and Supply group?
As a Senior IRT Specialist you will independently coordinate the set-up of studies in the IRT system for investigational trials in support of development programs.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Review of complex clinical study protocols, preparation and review of contracts for complex IRT set-up, programming information and maintenance of studies in the RAMOS IRTs
- Manages all aspects of the study following activation in the RAMOS IRT, e.g. supply management, communication with T2PS Project Leaders and Clinical study personnel, etc.
- Will participate in providing L2 Helpdesk support for Ramos NG
- Provide IRT technical support to Product Development, Clinical, and other GSK departments and lead Customer Complaints/Deviations
- Accountable for configuring complex studies in Ramos Classic and Ramos NG right-first-time assuring to meet agreed timings and requirements of the clinical customer utilizing appropriate blinding and supply strategies that reduce or eliminate any stock-outs to patients
- May include supervising staff
- Assess planned studies for suitability for RAMOS NG
- 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 (Xpress, eTrack, SPARC, etc).
- Responsible for drafting, amending, & determining gaps in SOPs, Std Works, GUID
- Write, participate, and lead 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 for their outsourced IRT studies
- Lead interactions with PCIT for operational system issues and drive future IRT enhancements. Good understanding of supply chain management
- Good understanding of randomization schemes and stratification factors
- Includes other activities as assigned.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Scientific degree or equivalent experience
- Minimum of 5-7 years related experience in IRT or clinical supplies
- Understanding of the development process and clinical supplies
- Demonstrates fundamental knowledge of GSO 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.
- Experience in working with customer relations
If you have the following characteristics, it would be a plus:
- 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
- Must exhibit excellent oral and written communication skills
- Good interpersonal skills
- Good planning and coordination skills
- Creative and innovative thinking
- Strong problem solving skills
- Drive for continuous improvement
Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness
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