RTSM Project Manager

As an RTSM Project Manager, you will be responsible for the design, development, testing, validation, execution, & maintenance of clinical studies in the Randomisation & Trial System Management (RTSM) system. You will be responsible for ensuring data integrity is maintained and driving /implementing continuous improvement across all Clinical Supplies systems. You will also be responsible for oversight of Clinical Studies by non-GSK RTSM Vendors. In this role you will

• Assess planned studies for suitability for RTSM system.
• Independently configure and manage/maintain complex RTSM 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 RTSM group business point of contact for technical systems (Randomisation 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.
• Analyse data and drive/implement continuous improvements.
• Provide technical guidance/support to Clinical Development for their outsourced RTSM studies.
• Lead interactions with RDIT for operational system issues and drive future RTSM enhancements.
• Develop supply strategy to eliminate stockouts, minimise waste and reduce shipments.
  
  We are looking for professionals with these required skills to achieve our goals:
• Bachelors degree or equivalent experience
• Significant experience in RTSM or clinical supplies required.
• Experience writing SQL queries and working with data from RTSM and/or Clinical Forecasting tools
• Deep understanding of Clinical trial forecasting concepts
• Deep understanding of Clinical trial resupply concepts
• Demonstrates fundamental knowledge of PDS - CSC computer systems.
• Proficient with writing SQL
• Ability to maintain accurate records and files in accordance with GSK policy, cGMPs, and SOPs
• A strong understanding of data modelling and data analytics
• Proven computing skills & experience with various software: Excel, Word, Powerpoint, Visio, MS Project, etc.
Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus:
• Basic understanding of clinical trial design
• Ability to interpret study protocols and understand the impact on RTSM design and supply of medicines to patients
• Ability to train others inside and outside the workgroup in area of expertise
  
  GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer., Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are., Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov