At Roche, we believe it is urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are brave in both decision and action; we believe that good business means a better world.
We are offering a unique opportunity to join SPE. In Systems and Process Excellence, we aim at being the trusted partner of choice; we partner across Clinical Operations to deliver services, solutions, and infrastructure that enable Roche to transform and optimise the way we run clinical trials.
The Clinical Records Manager collaborates with the Head of Clinical Records Management, to ensure our Trial Master File (TMF) and clinical archiving business needs are addressed in a proactive and timely manner.
In this role you:
Provide input to the development and enhancement of TMF processes and interfaces
Partner with SMTs to support their end to end lifecycle management of clinical archives
Are responsible for clinical archiving activities to be aligned with regulatory and internal standards (e.g. Coremap)
Are responsible to ensure alignment as appropriate to industry standards regarding the TMF reference model (eg: DIA) including impacted tools
Support during inspections in regards to TMF (remotely or on site), as well as internal GCP audits
Collaborate with Metrics and Information Management environment to ensure appropriate interpretation of TMF related data / information
Work with key partners to develop quality and compliance metrics across business units
Oversee external long term archiving vendor (e.g. Sispace), as well as other offsite long term archives (e.g. UK based archive)
Who are we looking for?
We are looking for highly committed individuals who bring:
A deep knowledge in Archive and Records Management requirements. Profound understanding of core processes in pharmaceutical drug development and health authority and compliance policies is key.
At least 5 years of relevant experience in the pharmaceutical industry and a university degree.
Highly flexible way of working: you are able to successfully handle activities with shifting deadlines
Remarkable interpersonal skills: you influence at various levels to reach consensus and achieve team objectives.
Customer focus: you build and maintain fruitful relationships with customers. You anticipate and meet immediate and long-term needs of customers, follow through on commitments and communicate realistic goals.
Analytical/Problem solving skills: you gather and integrate data with the ability to recognize inconsistencies and recommend solutions
Innovative and Creative Thinking: you seek improvements in work processes, while using judgment to balance creativity with compliance and the requirement to meet timelines.
Fluency in spoken and written English
Good working knowledge of ICH/GCP, particularly in TMF Management
Do you want to actively shape and simplify the Clinical Records Management world for study teams? Always through the lens of "Simplify, automate, eliminate" and a focus on technology?
Ready to apply?
If you still have questions then please check our FAQs and videos on careers.roche.ch/faq.
Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.Quality, Quality > Quality Systems