- Creating IRT/RTSM system forecasts, timelines and budgets on a trial and project level
- Reviewing the clinical trial protocols from an IRT/RTSM perspective and translating them into optimal IRT/RTSM systems designs.
- Developing User Requirement Specification (URS), preparing User Acceptance Test (UAT) incl. test planning, executing UAT and writing test reports
- Developing and maintaining IRT/RTSM related documents e.g. Validation plans and Risk assessments
- Managing IRT/RTSM suppliers, executing contracts, and evaluating supplier performance
- Coordinating and driving interactions between internal stakeholders and external vendors
- Giving input to project plans and budgets for the clinical trial supply deliverables
- Driving continuous improvement initiatives related to Clinical Trial Supply processes
- Keeping relevant SOPs updated
- Ensuring GxP compliant execution and documentation. Working according to GMP, GDP, GCP, SOPs and internal safety regulations
- MSc in pharmaceutical, or other relevant natural sciences
- Knowledge of IT system validation.
- Minimum 2 years' experience in pharmaceutical industry
- Knowledge of clinical trial operations, including drug development processes and regulatory requirements (incl. GMP and GCP)
- Proactive, flexible and service-minded approach
- Ability to work independently with some support from senior colleagues
- Strong communication and collaboration skills, with the ability to work effectively with different people and with cross-functional teams
Clinical Supply IRT/RTSM Specialist - Kastrup, Danmark - Ferring Pharmaceuticals
for 5 dage siden
Beskrivelse
Job Description:
Come help us deliver high-quality clinical trial supply to trials all over the world
At Ferring's Global Clinical Trial Supply Department we wish to expand our strong team of experienced Clinical Trial Supply Managers and Interactive Response Technology/Randomisation and Trial Supply Management system (IRT/RTSM) specialists, since exciting and challenging clinical trials are coming our way soon.
Ferring + you
We are looking for an IRT/RTSM specialist to help us ensure timely setup of IRT/RTSM systems to support the delivery of trial supply for Ferring clinical programs globally. At Ferring, the IRT/RTSM specialist works closely with the Clinical Trial Supply Managers, and together they are responsible for all aspects of trial supply management, from trial initiation to trial closure.
Your day at Ferring
Your main focus will be to drive the study-specific IRT/RTSM system setup and maintenance. Your responsibilities include:
In this role you are expected to not only collaborate closely with cross-functional teams but also contribute to a knowledge-sharing mindset and promote a collaborative and innovative work environment. You must have a flair for respectful communication with a range of stakeholders such as Clinical Operations, IT and Quality Assurance.
In Global Clinical Trial Supply, we continuously strive to optimise our processes; therefore, we expect you to be engaged in continuous development and improvement of our ways of working.
People come first at Ferring
When you join us in Global Clinical Trial Supply, you get a team of colleagues who care about and support each other. We preferably work in Trial Teams, and we have a high degree of interaction and collaboration within the department. We aim to have fun and we expect that you will contribute to maintaining our good work atmosphere.
Behind our innovation... There's you
We are looking for a profile with Clinical Supply experience and preferably experience with setup and maintenance of IRT/RTSM or similar systems. We expect that you have:
Behind our purpose... there's you
Please note that we review applications on an on-going basis and close the process when we find the right match.
Your primary work location will be the spectacular and state-of-the-art new domicile Soundport near Copenhagen Airport. We are unable to offer relocation assistance for this position. Candidates must be located in the Øresund region or willing to relocate at their own expense.
Location:
Ferring Denmark