Your new role:
We are looking for a 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. The CDM will report to the data center manager.
Clinical Data Management of BBRC projects The CDM will have to perform all aspects of data management to ensure BBRC meet the target deadline for analysis and be able to lock databases. The main function will be le 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 the data management team in developing Data Management procedures:
- The candidate will give support to the Data Center team in writing and implementing some determinate tools and procedures to improve clinical data management in the institution.
- Support the data center team by writing clinical data management procedures, guidelines, etc.
- Actively contribute to the institution high scientific standards.
- Assure and protect the respect of Good Clinical Practices (GCP) and legal restrictions (GDPR, etc.) in the BBRC Clinical Data Management.
- 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.
- 1 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.
- Spanish and Catalan preferred.
- English required.
- MedDRA and/or WHO coding, If applicable.
- Knowledge of CDISC standards (SDTM and AdAM).
What do we offer:
- Starting date: ASAP.
- Full time position: 38h/week.
- Permanent contract (6 month trial period).
- Salary will be in accordance with qualification and experience.
Application process:
1. To apply, please submit a single PDF file containing the following:
- Cover letter describing research interests and relevant background
- CV
- The names of up to three individuals who could provide reference letters.
2. All files or inquiries should be submitted electronically to: rh@barcelonabeta.org
- Subject: Junior Data Manager
- Deadline: 16th July 2021
CVs inscritos en el proceso: 22
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