Klinisk data manager (Assistant Clinical Data Manager)

The position
As Clinical Data Manager Assistant (CDMA) you will work with an international multi-center clinical study (ALLTogether) by supporting the Head CDM with clinical data management activities in the study. Over 140 clinics from 14 European countries will participate. The Sponsor of the clinical study is Karolinska University Hospital and all data management and central functions will be positioned with the Sponsor, located in Solna, Sweden. The clinical indication of the study is Acute Lymphoblastic Leukaemia (ALL) in children and young adults.

Your key responsibilities will be data management activities in the clinical study from study start to database lock. You will help to maintain the electronic case report form (eCRF) system and study web portal, monitor the study help-desk and assess study conduct (including centralised data review activities, a key component of Risk‐Based Monitoring). You will work as a member of the Sponsor and the Data Management team to ensure that data delivered to the Sponsor is in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), regulatory requirements and local standards. In addition, the role involves development and implementation of guidelines, Standard Operating Procedures (SOPs) and instructions to maintain the consistency in the data management process.

The data management team may expand to include an additional data manager when the study opens in more countries. Each country has their own Clinical Trial Unit which is responsible for country-specific monitoring of the study. In addition to the Head CDM, the position as a CDMA will involve close collaboration with the staff (monitors/project leaders) from these Clinical Trial Units in the participating countries in Europe, Statisticians, the Trial Central Office, the Chief Investigator and specialised working groups.

In addition to your data management work you will support the Trial Central office. This work may contain but is not limited to, administrative tasks, maintenance of the Trial Master File on the study level, and assisting in handling/maintaining the study budget.

The study is presently in its pilot phase.  The building and set-up of the eCRF is nearly completed and this system is developed and maintained by the Head CDM.  The pilot study has been ongoing in a limited configuration in the Nordic countries since August, 2019 and the comprehensive study in all European countries has a planned study start in the first quarter of 2020. The duration of the study is estimated to be 5
years of recruitment and 5 years of follow-up. 
Your profile
You are likely to have a university degree in Life Science/Health Science/Computer Science or equivalent. To be suited for this position, you should in addition have knowledge and experience of clinical data management in the academic clinical research/biotechnology/pharmaceutical industry and an understanding of what clinical trial data collection and quality control entails. You have experience from clinical trials, eCRF systems and computer system validation. It is a merit if you also have experience of budgeting. English and Swedish, both oral and written communication, is mandatory. 

You thrive in both individual and team constellations and have strong organisational skills. As a person you are driven, well-organised with attention to detail and have good coordinative and communicational skills. You should be open-minded to perform a variety of tasks within the clinical trial workflow.
För att din ansökan ska vara komplett ska den innehålla:
Personligt brev  
CV
Provanställning kan komma att tillämpas i denna rekrytering. Medarbetare som ska arbeta vårdtagarnära på Karolinska Universitetssjukhuset behöver fylla i en hälsodeklaration samt genomgå en enklare hälsoundersökning innan nyanställning.
Till oss kommer svårt sjuka barn från hela landet. Vi vårdar barn med kroniska sjukdomar, medfödda missbildningar, olika akuta tillstånd och tar hand om för tidigt födda barn. Temat bedriver specialiserad och högspecialiserad vård, och har ett rikssjukvårdsuppdrag för viss avancerad barn- och ungdomskirurgi.
Med ca 2200 medarbetare är Tema Barn - Astrid Lindgrens Barnsjukhus verksamt inom sju medicinska enheter och fyra omvårdnadsområden. Temat är organiserat i 20 patientflöden och ca160 patientgrupper inom barnsjukvårdsområdet.
Vi tar emot ca 180 000 patientbesök per år, varav 55 000 akuta besök och har en omfattande klinisk forskning, utveckling och undervisning med brett internationellt samarbete. Vård bedrivs på Karolinska Universitetssjukhuset i Solna och i Huddinge samt på Danderyds sjukhus.
Karolinska Universitetssjukhuset är ett rökfritt sjukhus!
Vid tjänst som innefattar vård av barn och ungdom kommer Karolinska Universitetssjukhuset att kontrollera den som erbjuds tjänsten mot belastningsregistret.
Vi eftersträvar jämställdhet och jämlikhet på vår arbetsplats och ser gärna sökande med olika bakgrund och förutsättningar.
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