Idipaz is looking for a Data Manager with MedDRA coding training (AB2)

We are seeking a highly motivated graduate in Statistical Sciences and Techniques with training in Coding with MedDRA, with training in Good Clinical Practice and Clinical Data Manager experience acquired in CRO and collaborative groups and currently participating in active Research projects.

Specific training in courses, seminars related to the position

SKILLS

Specific training
MedDRA Coding Training
Good Clinical Practice training
 
MERITS
Specific training
Courses, seminars related to the position
Experience
Clinical Data Manager acquired in CRO and/or collaborative groups
Participation in active research projects
Computer tools
DB management and statistical software and medical coding dictionaries: Microsoft
Office, MACRO® (administrator level), REDCap (administrator level), Microsoft SQL Server,
MySQL (administrator level), phpMyAdmin, ClinTrial, SDTM and CDISH structures, WHODRUGS,
MedDRA, SPSS and SAS.
Languages
English, medium/high level

The duties involved in the position consist of:

- Elaboration, development, implementation and validation of CRDs/e-CRDs, as well as the programming of edit checks and
programming of edit checks and data listings according to the required protocols and specifications.
required specifications. 
- Design and validation of data collection tools, databases, data management systems and related applications.
management systems and related applications.
- Develop specifications and procedures for the transfer of data to SAS
according to the needs of statistical analysis. Collaborate with statisticians
in data analysis.
- Develop Data Management Plan (DMP) for clinical trials. Annotation of
CRDs.
- Conduct Research Data Management training workshops for Investigators.
- Document all programming and procedures to ensure accurate historical tracking of all management activities.
historical tracking of all data management activities in a clinical trial.
- Clinical data management, including review of CRD data, generation of queries and their resolution, review of
queries and their resolution, data review, medical coding and quality control procedures.
quality control procedures. 
- Prepare clinical trial data status reports. DB closure tasks and all activities related to the final clean-up of the data including contacting the sites for
data including contacting sites to resolve outstanding queries. 
-Development of standard operating procedures (SOPs) for the standardisation of data management processes in the clinical trials.

He/she shall be familiar with the applicable clinical trials and data quality regulations and any other applicable regulations

• Indefinite-term employment contract for scientific and technical activities.
• Professional category of Assistant Researcher, Group II, Area 2, according to the collective bargaining agreement.
• Full time of 37.5 hours per week.
• Gross annual salary: €27.052,31
• Private matters: 6 working days per year.
• Vacation: 22 working days per year.
• December 24 and 31 are non-business days.

The selection process will consist of two phases and the following scale will be applied, out of a maximum of 10 points:

-Training and curricular merits: 6 points.
-Personal interview: 4 points

In the event that two or more candidates match the values and needs of the institution and meet the conditions required for the post, and where there is a tie, the candidate with a certificate attesting to a minimum degree of disability equal to or greater than 33 per cent shall prevail.

1) Documentation to be submitted by each candidate:

• Updated curriculum vitae.
• Document certifying academic qualifications.
• Voluntarily inform if you belong to a disadvantaged group or justify any possible career leaps.

2) Incorporation and place of work

• Contract start date: October/November 2023
• Place of work: Foundation/IdiPAZ

3) Documents of interest to candidates. They can be consulted on the official IdiPAZ website: https://www.idipaz.es/PaginaDinamica.aspx?IdPag=9&Lang=ES

- Collective Bargaining Agreement of the Group of Companies of the Biomedical Research Foundations of the Health Institutions attached to the Madrid Health Service (SERMAS).
-Scales to be used to evaluate the applications (varies according to the offer)

- Professional development opportunities within the institution:
-OTM-R Policy
- IdiPAZ equal opportunity policies

- Data Protection Manual