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).
- Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
- 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:
- The candidate will give support in writing and implementing some determinate tools and procedures to improve clinical data management in the organization.
- 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.)
- Working knowledge of Clinical database applications such as EDC and CTMS.
- 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).
