Job description
Posted Date: May 2 2023
RTSM Project Manager (Remote)
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.
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.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelors degree or equivalent experience
- Minimum of 5 years related experience in RTSM or clinical supplies required.
- Minimum of 3 years 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
- Proficient with writing SQL
- A strong understanding of data modelling and data analytics
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
Closing Date for Applications: Tuesday 16th May 2023 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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#LI-GSK
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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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