Basel, Basel, Switzerland
15+ years experience in clinical development across different indication and regulatory requirements. Passionate to see how our industry is changing with the new technology available. I passionate about the whole process from defining a research question until the moment you have the data in your hands. Data is not enough, you have to communicate it: I do strongly believe that if data is prepared & visualised in a better way having the end user in mind will have an immediate impact as better and faster decision can be made.
Driving actively Digital Transformation Leading a digital transformation project where we establish a process/platform to link and work with big internal and external data sets: • Transfer of non-digitized data eg. form scanned copies into electronic, analyzable data; • Defining a common data model based on an internationally accepted model and transforming heterogenous data into this; • Defining and establishing a standard process for ingesting, cleaning, and linking data from diverse internal and external source (data flow); • Use of Bayer Consumer Health Data & Analytics platform (Azure Data Lake) • Establish a cost-effective data analytics framework Key contribution: • Development of the initial idea/vision • Stakeholder management • Operational conduct (including exchange with the external provider), • Problem shooting, input in the analytical plans and report, data visualization. • Development of a Handbook for Clinical Data Analytics Development of an anyltical dashboard which provides new insights on our portfolio via linking data from different sources. Key contribution: • Initial idea/prototype • Support of the team in design aspects of the Dashboard and input in the overall strategy of the implementation of the Dashboard into the organization. Leadership • Managing a Team of 5 with heterogenous tasks (Biostatistics, Qualtiy Management, Archiving, non-clinical operations) based in US, Switzerland and Russia. Clinical Development support : • Input into the clinical development plan, study protocol for the pilot and the confirmatory study, scientific advice meeting working together with the relevant functions (medical, safety, regulatory) • Operational supervision from out contacting, reviewing data management plan, SAP, monitoring reports, clinical study reports.
Responsible for the clinical development strategy with a focus on strategy, feasibility, success full planning an execution of initatives. Support the biggest initiative for the digital transformation at Bayer Consumer Health. With a small team we support the initiative by leveraging existing data through smart connection and data visualisation (Tableau) with the aim to bring quickly new insights for better decision making to the different stakeholders. Continuing to further develop and maintain a claims data base containing not only active country marketing claims but also the relevant substantiation linked. The database helped already to leverage know-how and experience on claims amongst all countries and it allows to see the global functions to see what works and what not in the markets. Responsible for the operational conduct of pre-clinical/non-human studies.
- Managing a Team of 6 who execute operationnaly clinical studies of all type in the area of nutritional, personnel care and therapeutics. - Setting up with the team new data management capabilities with a state of the art eCRF/ePRO system (Viedoc) so that for any type of study data can be collected in a fast and tailored way avoiding any unnecessary costs but with the necessary quality. - From concept to execution building up a highly structured claims database which includes not only the approved claims from the countries but also the global substantiation. Linking the the data with the already available information provided with the product life cycle management system, the regulatory database, clinical and pre-clinical study reports as well as published Literature. - Implementing self-analytic Tools (Tableau, Tableau Prep) to make the data available in a meaningful way to a broader community within Bayer (Business, Business Development, Regulatory, Product Supply) & building up an internal cross-functional community to drive data linking, data visualisation and data self analytics. - Set-up successfully a non-interventional study in Russia using for the first time ePRO in Russia for this type of study. - Operationally support toxicology studies conducted for Bayer Consumer Health.
– responsible for investigator supported trials – GCP and SOP training for medical managers – mentoring of new employees – writing of protocol and CRF – member of the steering committee – organization of a training for study nurses
–coordination of local and international clinical trials (phase II-IV in oncology and virology) –setting up local multi center trials including data management –authoring study report –monitoring –preparation of the submission for the ethic committees –correspondence with the regulatory authorities –correspondence with data manager/statistician –organization of investigator meetings –establishing and structuring the intranet page for the clinical research group
-research on the function of the gene “minibrain” in Drosophila melanogaster with cell biological methods
-Molecular- and cell biological experiments with Schizosaccharomyces pombe