Manager Data Management RWE – Neuchatel, Switzerland
Be a part of a revolutionary change.
At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products.
With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.
It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products.
Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers.
If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future
Your ‘day to day’
As a Manager Data Management RWE, you will provide expertise in data management to design, conduct and report RWE and clinical research studies that aim at understanding the health impact of products in our portfolio (e.g., alternative products to cigarettes). You will work closely with other functions (legal/data privacy, epidemiology, statistics, programming) to design and implement robust data flows, i.e., data exchange protocols including data security protocols, between different data partners. You will translate strategic needs into innovative data management solutions, ensuring PMI follows data privacy laws and data are securely exchanged while increasing result delivery speed, as well as formatted and exchanged with regulators (mainly FDA). You will supervise the work of Clinical Research Organizations (CROs), follow-up budget and lead data management activities.
More specifically, you'll
Act as data management specialist for the assigned portfolio of RWE studies. Namely, you will be responsible the design and implementation of the data flow between different parties exchanging data as part of 1-4 RWE studies.Ensure data exchanges are secure, respect data privacy laws and data are formatted to be shared with regulatory bodies (mainly FDA).Ensure that regulatory or industry guidance on data formats and internal quality processes pertaining to data management are followed for the assigned studies.Serve as a technical leader in data management. Guide and supervise the selection of appropriate formats and exchange methodologies between parties by CROs to ensure evidence generation of the highest scientific quality. You will be part of the Study Team(s).Maintain an up-to-date knowledge of data standards and regulations. Oversee all data management activities of the assigned RWE studies by drafting (or asking the CRO to draft), reviewing and approving all documents and deliverables of the assigned studies related to data exchanges and data privacy.Lead CROs, track progress of data management activities against agreed timelines to ensure that all appropriate activities have been performed and delivered on time with the expected quality.Participate in the writing, review, and update of quality documents.
Who we’re looking for
MSc degree in Life Sciences, Statistics or Data management, or equivalent experience and skills.Substantial experience in a pharmaceutical, medical devices, consumer goods, or a clinical research environment is required. Ability to lead the work delivered by CROs is required.Experience working with data from claims, EMR (electronic medical records) and data issue from questionnaires is required.Knowledge of OMOP-CDM is required. Knowledge of CDISC (SDTM, ADaM), HL7, FHIR is an advantage.Flexibility to elaborate creative solutions to complex data exchange is required.Knowledge in privacy-preserving linkage methodologies (tokenization, API) is an advantage.Knowledge of data privacy laws in the EU, Japan and North America is an advantage.Excellent interpersonal communication, organizational and leadership skills with ability to work both independently and in a team environment are required.Proficiency with Excel, PowerPoint, and Word is required.Fluent in English, both written and spoken.
What we offer
Our success depends on the people who come to work every single day with a sense of purpose and an appetite for progress.
Join PMI and you too can:
Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore.Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress.Take pride in delivering our promise to society: a smoke-free future.
The position is located in Switzerland with a minimum of 40% presence time in the Neuchatel office
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