Lina Castaneda
Chemical Engineer / Microbiologist
Bogota,Cundinamarca
Summary
Enthusiastic LCDM eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of data review and compliance and training in effective communication. Motivated to learn, grow and excel in Pharmaceutical industry. Dedicated to using excellent research, investigation and project management abilities to optimize management, organization and reporting of clinical data. Results-driven, precise and systematic with quick learning and collaborative nature.
Overview
3
3
Languages
21
21
years of post-secondary education
6
6
years of professional experience
Work History
Lead Clinical Data Manager
MSD
Bogota, Cundinamarca
09.2016 - Current
- The LCDM is responsible for executing end to end Data Management activities being the main GDO contact for the Study Team.
- Coordinates Data Review Activities with SCDM and CDM Staff at Protocol Level and provides mentoring as needed.
- Encourages effective interaction of Data Management Center (DMC) staff with business partners to achieve common objectives.
- Communicates with sites and country CRAs to ensure visits are promptly entered and queries are promptly escalated and resolved.
- Accountable for the quality, and timely execution of deliverables at the trial level for Global Data Operations (GDO) as well as the key performance indicators according to the process expectations.
- Creates and maintains the following data management deliverables:
-Edit Check Specification
-Encoding Specification
-Data Review Plan (includes In Life Reports)
-eCRF Entry Guidelines - Reviews and provides input to the following data management deliverables:
- eCRF
- T&E
- Home Page
- Data Management Plan - Coordinates User Acceptance Testing of Data Bases, Document Archiving and External data activities. Participates in Change Request Process as per SOP.
- Helps o resolve data issues and questions from the Data Management Centers and Clinical Trial Team.
Senior Clinical Data Manager
MSD
Bogota, Cundinamarca
03.2016 - 08.2016
- The SCDM is responsible for executing end to end Data Management activities with the support and oversight of LCDM.
- Reviews data entered by investigational site staff, uses exception reports to identify data inconsistencies or departures from eCRF Entry Guidelines. Issues queries and follows them up until resolution. Escalates issues to LCDM as corresponds according to each process.
- Supports LCDM in the creation and review of Trial Deliverables, document archiving, UAT of Data Bases, External Data activities and related trial assignments.
- Monitors, tracks issues/ resolutions and provides LCDM Protocol Status to collaborate with the follow up of the Key Performance Indicators.
- Provides support / training to CDM and other SCDM as needed.
- May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).
Clinical Data Manager
MSD
Bogota, Cundinamarca
04.2015 - 02.2016
- The SCDM is responsible for executing end to end Data Management activities with the support and oversight of LCDM.
- Reviews data entered by investigational site staff, uses exception reports to identify data inconsistencies or departures from eCRF Entry Guidelines. Issues queries and follows them up until resolution. Escalates issues to LCDM as corresponds according to each process.
- Supports LCDM in the creation and review of Trial Deliverables, document archiving, UAT of Data Bases, External Data activities and related trial assignments.
- Monitors, tracks issues/ resolutions and provides LCDM Protocol Status to collaborate with the follow up of the Key Performance Indicators.
- Provides support / training to CDM and other SCDM as needed.
May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).
Education
Bachelor of Science - Microbiologist
Universidad De Los Andes
Bogota 08.2009 - 01.2012
Bachelor of Science - Chemical Engineering
Universidad De Los Andes
Bogota 08.2005 - 07.2011
High School Diploma -
Colegio Refous
Cota 02.1992 - 11.2004
Skills
Team Building
Timeline
Lead Clinical Data Manager
MSD
09.2016 - Current
Senior Clinical Data Manager
MSD
03.2016 - 08.2016
Clinical Data Manager
MSD
04.2015 - 02.2016
Bachelor of Science - Microbiologist
Universidad De Los Andes
08.2009 - 01.2012
Bachelor of Science - Chemical Engineering
Universidad De Los Andes
08.2005 - 07.2011
High School Diploma -
Colegio Refous
02.1992 - 11.2004
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