Highlights:

Skills:Clinical Data Manager, CDM, Clinical Data Coordinator

Clinical Data Coordinator II 07/2023 - current
ICON plc, Bogota D.C, Bogota D.C Colombia
Industry: CRO
Supports and executes the data review activities, including data validation and analytics associated with a clinical trial to ensure the end product of clinical meets agreed upon data integrity standards.
- Participation on Protocol Milestones: DSUR, Biannual safety Update, DBL - Local Labs processes: Data Entry and quality control. - Support portfolio of clients by performing data review activities using JReview, metrics to ensure meeting the client’s expectations and requirements, implementation of listings. - Performs root cause analysis of detected data issues. - Detects risk and signals in the data using quality indicators. - Supports activities related to development of the clinical data management systems (CDMS), as needed.--
Clinical Data Manager 11/2021 - 06/2023
MSD, Bogota D.C, Bogota D.C Colombia
Industry: CRO
Responsible of data collection, data integrity review and reconciliation, query management and data base lock preparation in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
- Participation on Protocol Milestones: Submission Interim Analysis, Safety IA, Final DBL - Support Portfolio by data review activities of Standards, Oncologic, and E2E external data, as well as MPRs. - Support Protocol Level Quality Checks and Global Data Validation Quality Assessments to ensure quality in the data review and reconciliation. - Collaboration with Senior Data Manager and Lead Data Manager to build Edit checks, UAT testing, Data Entry Guidelines, Data Review Plan and Ad Hoc reports. - Successful back up on the mentoring process of new hires.--

Universidad Manuela Beltran 02/2014 - 10/2020
Bogota D.C, Bogota D.C, Colombia
Degree: Bachelor's Degree
Major:Biomedical Engineering
I graduated as a Biomedical Engineer in 2020. I did a course in project management for biomedical engineering projects and did an investigation on technologies for people with disabilities.

CDM_DanielaJara_Resumee