- JOB
- Spain
7 Jun 2023
Job Information
- Organisation/Company
- IdiPAZ
- Department
- Clinical Trials Unit
- Research Field
- Medical sciences » Medicine
- Researcher Profile
- First Stage Researcher (R1)
- Country
- Spain
- Application Deadline
- Type of Contract
- Permanent
- Job Status
- Full-time
- Hours Per Week
- 37.5
- Offer Starting Date
- Is the job funded through the EU Research Framework Programme?
- HE
- Reference Number
- 101104360
- Is the Job related to staff position within a Research Infrastructure?
- No
Offer Description
- Design and validation of CRDs/e-CRDs, as well as the programming of edit checks and data listings according to the required protocols and specifications.
- Develop specifications and procedures for data transfer to SAS according to the needs of statistical analysis. Collaborate with statisticians in data analysis.
- Develop Data Management Plan (DMP) for clinical trials.
- Document all programming and procedures to ensure accurate historical tracking of all data management activities in a clinical trial.
- Clinical data processing, including CRD data review, query generation and resolution, data review, medical coding and quality control procedures.
- Prepare reports on the status of clinical trial data.
- DB closure tasks and all activities related to final data cleansing including contacting sites to resolve outstanding queries.
- Development of standard operating procedures (SOPs) for the standardisation of data management processes in clinical trials.
- Be familiar with the applicable clinical trial and data quality regulations and any other applicable regulations.
Where to apply
- alberto.borobia@salud.madrid.org
Requirements
- Research Field
- Medical sciences » Medicine
- Education Level
- Master Degree or equivalent
Skills/Qualifications
Communication, collaboration, and problem-solving skills
Effective time management skills
Strong attention to detail
Good presentation skills
Proven flexibility and adaptability
Specific Requirements
• Degree in engineering
• Master's degree in Research in Clinical Medicine
• Previous experience as Clinical Data Manager acquired in CRO and/or collaborative groups
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Knowledge of Database Management software (Advanced MACRO® Training, Microsoft SQL Server (Administrator level))
• Knowledge of Statistical Management software (SAS)
• Knowledge of Data Management Standards (SDTM and CDISH structures, OMOP Common Data Model )
• Knowledge of Medical Coding dictionaries (MedDRA® Coding Training)
• Good Clinical Practice Training
• Availability to travel and should possess a valid driving license
- Languages
- ENGLISH
- Level
- Excellent
Additional Information
Work Location(s)
- Number of offers available
- 1
- Company/Institute
- IdiPAZ
- Country
- Spain
- State/Province
- Madrid
- City
- Madrid
- Postal Code
- 28046
- Street
- Paseo de la Castellana 261
Contact
- State/Province
- Comunidad de Madrid
- City
- Madrid
- Website
- Street
- Paseo de la Castellana 261
- Postal Code
- 28046
- alberto.borobia@salud.madrid.orgrecursoshumanos@idipaz.esinternational.projects@idipaz.es
- Phone
- 912071790