- 58 jaar
Rijbewijs en talenkennis
- B - Personenauto
- C - Vrachtwagen
Dit ben ik
Mijn dromen en ambities
I am a clinical data analyst and have been working within the pharmaceutical industry for nearly 20 years. In my most resent function I have been focused on the collection of high quality clinical information from the centralized Laboratory vendors (Lab, ECG, MRI etc.), into the study database for review and reporting. Have setup instructions for data vendors, done the needed User Acceptance Testing. Had daily contacts with ceveral central laboratorie representations in most time zones. Supported direct colleagues in their efforts in getting aqainted to the job, and the use of working platforms.
I have worked result driven, timeliness and quality, and team work has always been the glue of the department.
If this leaves you with questions, get in contact, I would like to elaborate further.
Ik wil graag werken als
Wat breng ik mee?
Mijn huidige situatie
2009 - : EDAO (External Data Acquisition and Operations) analyst.
• Primary task of setting up specifications for data transfer and the daily contacts with the Central Laboratories for specific studies.
• Maintained transfers in accordance with allocated SOP’s for studies residing in the legacy setup.
• Took over the Adverse Event collection for studies which had the database outside the company. As this information is being used for disclosure towards authorities (NIH) quality and timeliness are of high importance. Being the single person supporting the actual collection, I was repeatedly rewarded with the appreciation of internal and external contacts for the way I was able to get the needed quality and the thorough way I guided new teams with their DB retrievals.
• Held interdisciplinary meetings in order to have data coming in on basis of a new diary card to uphold the CDISC guidelines. In order for the reporting database to be SDTM compliant and available for biometrics.
2002 – 2008: Clinical Data Analyst
• Performed large scale studies for multiple years of duration.
• Department switched from Clintrial as main data management platform to Oracle Clinical.
• Performed the testing of additional programmed queries.
• Supported the electronic storage initiative of the department where the data received on paper CRF’s where digitized. I was able to help keep the hardware running and lent some first line support as soon as data connectivity was a problem.
• Completed data entry training in legacy system was thus able to expedite late arriving Adverse Event data, thus maintain DB lock dates under compromised circumstances.
2001 – 2002 : In order to accommodate local first line ICT support. And further personal knowledge concerning the programming site of the query handling within the department. I embraced this double function.
• On the programming site I was able to adapt and update single DVD’s that did not develop enough skills to do full studies.
• The first line ICT support was highly appreciated by colleagues. Changes in the ICT structuring changed the support lines and thus first line support also restructured.
1995 – 2001: Full member Data Management department
• GCP and NIH guidelines educated and trained as base reaction set.
• Use and handling of Clintrial as the data management platform was enhanced.
• Participated in larger clinical studies with several data managers to handle the work load.
• Had the opportunity to do a single Investigator study until completion (locked database and data management report). The study team, investigator and the site staff were all fully satisfied with the collaboration.
1993 – 2014 : The training received for the specific tasks of Data Manager and EDAO analyst were provided as on the job training (by peers), via electronic media or courses. These trainings have a definite company character, parts of those trainings had to be re-taken in order to be tuned to the needs of the protocols being worked upon.
1989 : Post-Graduation course Medical parasitology
1984 – 1989 : HLO, Hogeschool Utrecht (zoological analist) Apprenticeship with Research group for Veterinary Pharmacy Pharmacology and Toxicology
1983 – 1984 : Propedeuse HLO, Zuid-Limburgse Laboratorium School Sittard
1977 – 1983 : High School (HAVO), Rijks-Scholengemeenschap Roermond
Meer over mij
Zo besteed ik mijn vrije tijd
Flyfishing, flytying, Cycling Scuba-diving (not active)
- Oss 50km