Clinical Data Manager

hace 3 días

Madrid, España Oxford Global Resources A tiempo completo

**Clinical Data Manager**:

- Location:
Madrid, Spain
- Contact:
Susagna Sastre Magem
- Job type:
Temp to Perm
- Industry:
Pharmaceutical, Life Sciences, Management Consulting, Clinical Research
- Oxford Global Resources is looking for a Clinical Data Management who will have to perform all aspects of data management to ensure our client located in Madrid meets the target deadline for analysis and is able to lock databases._
- The main function will be the following ones:_
- _
- _Preparing, conducting and completing Clinical Data Management tasks according to institution policies, guidelines and regulatory requirements._
- _Review Study Protocol and develop corresponding electronic data collection (EDC)._
- _Responsible to prepare, maintain, finalize and archive all related Data Management documentation: Data Management Plan and Data Management Report, Data Validation Plan (including definition of edit checks)._
- _Perform training on study trial for EDC and create user guides._
- _Supervise the development of Data Entry Instructions/ EDC and eClinical chart completion guidelines._
- _Define and supervise the programming of edit checks._
- _Perform Data cleaning and query handling._
- _Carry out all tasks related to database closure._
- _File/archive essential documents._
- Support in developing Data Management procedures:_
- _
- _Support the data center team by writing clinical data management procedures, guidelines, etc._
- _Carry out all tasks related to database closure._
- _File/archive essential documents_
- What do we need from you:_
- _
- _University degree in Science (preferred life science, psychology, medicine or statistics)._
- _A bio statics training or experience will be considered positively._
- _3-4 year of relevant data management experience in Research (CRO, Pharma-Industry, Cooperative research groups, etc.)_
- _Experience in database management programming (SAS, SPSS, R, SQL...)_
- _Perfect knowledge and training to GCP will be positively considered._
- _English required._
- _MedDRA and/or WHO coding, If applicable._
- _Knowledge of CDISC standards (SDTM and AdAM)._

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