We are looking for a Junior Clinical Data Manager (CDM) to give support to the Data management team and to perform research data management activities in order to deliver high quality data.
Responsibilities:
- 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.
Requirements:
- University degree in science (preferred life science, psychology, medicine or statistics).
- A biostatistics training or experience will be considered positively.
- Minimum 1-year relevant clinical data management experience in Clinical 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, etc...)
- Perfect knowledge and training to GCP, etc. will be positively considered.
- Spanish and Catalan preferred.
- English required.
- MedDRA and/or WHO coding., if applicable.
- Knowledge of CDISC standards (SDTM and AdAM).
