Who I am
My name is Natalie and I have more than 18 years of experience in the area of Clinical Data Management in the Pharmaceutical industry.
Throughout my career I have worked for a mid-size CRO as well as for bigger pharamaceutical companies such as UCB and Bayer.
In my freelance projects I had the opportunity to support a mid-size CRO as a Lead Data Manager to rescue a study from a home-grown EDC system into Viedoc.
Furthermore I have joined a Clinical Operations Team in NIS oncology of a Biotech company to support all their projects as an external Data Manager.
Please visit my LinkedIn profile to view my professional experience in more detail or reach out and I'll be happy to provide you my portfolio profile.
For me, the main motivation to be a freelancer is the variety of different projects where I can help teams to solve specific problems and at the same time to learn and grow personally, as well.
When you are looking for an experienced Clinical Data Manager and/or Clinical Data Programmer to support your projects on a freelance basis, I would be happy to hearing from you.
Send me a message via the contact form.
What I offer
The below tasks are not a full list of expertise which I could bring into your projects. If you think I can support you in any other area, please contact me.
- Design and development of eCRFs (electronic Case Report Forms).
- Validation of eCRFs (edit checks programming), data cleaning activities, SAE reconciliation.
- Creation of reports and listings to support medical data review.
- Change management of eCRFs.
- Creation of Data Management related documentation (Data Management Plan, Data Validation Plan, Test Plan, Testing Log, Data Entry Guidelines etc.).
- Training of end users (CRAs, Study Nurses, Investigators) and project-related support.
- Support in database lock activities.
- Creation of electronic Data Transfer Specifications and execution of external data import (e.g. lab data).
- Support in standardization of data acquisition elements.
- CRO oversight
Skills
Clinical databases:
- Castor EDC
- Medidata RAVE (eCRF set-up and edit checks incl. Custom Functions programming) - most experienced
- Veeva Vault CDMS
- Oracle Clinical
- OC RDC
- iCRF
Programming languages:
- C# (Custom Functions Programming in Rave)
- Java
- JavaScript
- HTML
- XML
- SQL
- PL/SQL
- SAS (basics)
- R (basics)
Soft skills:
- Committed and focused
- Effective and efficient way of working
- Structured and planned
- Efficient communication
- Team player
- Finding pragmatic solutions
Tools:
- Metadata Repository (Sycamore MDR)
- Accenture Life Science Cloud - Data Management Workbench (ALSC - DMW)
- TrialGrid
- Toad
- eLoader
- SAS console
- Pinnacle 21
- Subversion
- Business Objects
MS Office:
- Word
- Excel
- PowerPoint
- OneNote
- Outlook
Languages:
- German (native)
- English (fluent)
- Russian (fluent)
My motto
"JUST DO IT."
Nike
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