RTSM Project Manager (Randomisation and Trial Supply Management)

GSK; Stevenage; On-site; GBP 70,000 - 95,000; Full time

Job summary

GSK’s Core-Tech RTSM team in the UK develops and sustains RAMOS IRT systems for clinical trials. The RTSM Project Manager designs, tests, validates, and maintains RAMOS IRT studies and oversees studies managed by external vendors, ensuring data integrity and continual process improvement.

You will partner with internal and external stakeholders, potentially line-manage on projects, and drive improvements across Clinical Supplies systems while supporting Helpdesk operations as needed.

Qualifications

• Degree in a relevant field (Science, Supply Chain, Tech)
• Experience with clinical supplies/trials and IRT
• Experience managing projects and governance with senior stakeholders

Responsibilities

• Assess planned clinical trial studies for RAMOS IRT suitability and configure complex IRT designs
• Act as IRT business point of contact for technical systems; own improvements and training gaps
• Identify issues and propose solutions; raise deviations, CAPAs and SOP gaps
• Lead interactions with RDIT for system issues and drive IRT enhancements
• Develop supply strategy to reduce stockouts and waste
• Assist Helpdesk during daytime hours and participate in on-call rotations

Skills

RAMOS IRT

Data mining

Data analysis

SQL databases

Statistical analysis

Data modeling

SQL

Data storytelling

Education

Relevant degree (Science / Supply Chain / Technical)

Tools

RAMOS IRT (Interactive Response Technology)

Job description

The Core-Tech RTSM team sits within GSK's R&D Medicine Development and Supply division. It has responsibility for managing key components for GSK's clinical trial process, utilising RTSM (IRT) (Randomization Trial Supply Management - also known as: Interactive Response Technology) to help the company deliver its R&D objectives. The RTSM Project Manager is responsible for the design, development, testing, validation, execution, and maintenance of clinical studies within the RAMOS IRT (Interactive Response Technology) system. The responsibilities of the role extend to oversight of Clinical Studies managed by non-GSK IRT Vendors. In delivering the role you will ensure data integrity is maintained, whilst driving and implementing continuous improvement across all Clinical Supplies systems. In delivering this role you will partner with and act as the key-interface with a wide variety of internal and external stakeholders and suppliers (and you may have direct line-management responsibilities depending on projects). Key Responsibilities (include..,):

• Assess planned clinical trial studies for suitability for RAMOS IRT (Interactive Response Technology) system, and independently configure and manage complex IRT study designs (including international or more complex / adaptive designs).
• Act as IRT group business point of contact (as required) for technical systems (Randomization and Container Code, Packaging, and Shipping Systems). Accountable for identifying, owning, and implementing process improvements and training needs & gaps.
• Proactively identify and communicate issues as well as proposing solutions. This extends to raising Deviations/Customer Complaints and associated CAPAs and drafting, amending and determining gaps in SOPs.
• Lead interactions with RDIT for operational system issues and drive future IRT enhancements. Analyse data and drive/implement continuous improvements as well as provide technical guidance/support to Clinical Development for their outsourced IRT studies.
• Develop supply strategy to eliminate stockouts, minimize waste and reduce shipments.
• Assist with Helpdesk during daytime hours (as needed) and participating on Helpdesk Stand‑by/On‑Call rotations (nights, weekends, holidays).

Please Note: Helpdesk out of hours support is typically 1 day a week and 1 weekend a month. This element of the role will be discussed at interview.

• Relevant Degree (eg; Science, Supply Chain, Technical, etc).
• Experience / Knowledge of clinical supplies/trials (including IRT knowledge/experience).
• Experience of managing projects.
• Understanding / knowledge of project governance and escalation processes including senior stakeholder communication and reporting., Business Data Mining, Data Analysis, Data Analysis Tools, Data Mining, Data Modeling, Data Storytelling, SQL Databases, Statistical Analysis, Structured Query Language (SQL)

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.

Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from any actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 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

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $113,025 to $188,375. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
• If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
• Belgium Salary Range / Fourchette salariale - Belgique: EUR 72,225 to EUR 120,375
• The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.