Assistant Clinical Data Manager

We offer
As a Clinical Data Manager (CDM) you will work with an international multi-center clinical study (ALLTogether) by supporting the Data Management team with clinical data management activities in the study.
Several countries are currently enrolling patients, and over 140 clinics from 14 European countries are planning to participate.
The Sponsor of the clinical study is Karolinska University Hospital and all data management and central functions will be positioned with the Sponsor, with offices at Karolinska Institutet in Solna, Sweden.
The clinical indication of the study is Acute Lymphoblastic Leukaemia (ALL) in children and young adults.
Your position
Your key responsibilities will be data management activities in the clinical study from study start to database lock.
You will help to maintain and when needed adapt the electronic case report form (eCRF) system (Castor EDC® - http://www.castoredc.com ) 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 central 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.
Each country has their own Clinical Trial Unit which is responsible for country-specific administrative tasks and on-site monitoring of the study. In addition to the central Data Management team, the position as CDM will involve close collaboration with the staff (monitors/project leaders) from these Clinical Trial Units in the participating countries in Europe, the study Statisticians, the Trial Central Office, the Chief Investigator, National Principal Investigators and specialised Working Groups.

A major role of the CDM is to carry out all tasks according to the Data Management Plan and Data Management SOPs, including maintaining the eCRF system and ensuring that it is functioning according to ICH/GCP and regulatory requirements, and that all users in the system are carrying out activities in accordance to their predefined roles.
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.
The pilot study has been ongoing in a limited configuration in the Nordic countries since August 2019, and the comprehensive main study for all planned countries began recruitment in July 2020. The duration of the main study is estimated to be 5 years of recruitment and 5 years of follow-up. 

Your profile
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.
Qualifications
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 must have experience from clinical trials and eCRF systems.
It is an advantage if you also have experience from system validation and knowledge or working experience with the Castor EDC eCRF system, the randomization system ALEA, datasets and/or programming skills (e.g. JavaScript, R) are strong merits. 
Adept knowledge of the Microsoft Office Suite (Excel) is required.
Professional fluency in English, both oral and written communication, is mandatory. Professional fluency in Swedish is a strong merit.

In order for your application to be complete it must include the following;
1. CV
2. Application Letter

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.

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