MARICRUZ ROJAS LEAL
Curridabat,SJ
Summary
Experienced nurse with a passion for the pharmaceutical industry and a strong background in human care and life sciences. Committed to leveraging expertise to enhance people\'s quality of life through research and innovation. Seeking opportunity to contribute skills and knowledge to a dynamic team focused on improving healthcare outcomes and advancing medical advancements.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Data Manager
MSD
05.2024 - Current
- Carried out the proper management of the data generated by clinical trials, and ensured that data is collected as per the requirements of the study protocol and that it is free from any errors before it is analyzed
- Collaborated with cross-functional teams to drive the successful execution of clinical trials.
- Reduced data discrepancies through the implementation of robust validation checks and error resolution procedures.
- Led a team of data management specialists to ensure timely completion of project deliverables.
- Streamlined clinical trial processes for improved efficiency and reduced study timelines.
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
Imaging Research Associate I
Clario
06.2023 - 05.2024
- Coordinated all site and operational activities, from study start to study close, to ensure the timely delivery of high-quality service deliverables for assigned studies.
- Assist in preparation and reproduction of study materials during study start-up phase of clinical trials Follow up with outstanding documentations from clinical sites to complete site qualification Schedule logistical and technical trainings with site personnel Create test run requests for sites submitting digital data Review, process, track and monitor all study related data received from sites
- Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors Investigate and complete logistical edit checks Report issues found with study systems (i.e. study database, reading analysis system) Perform day to day IQC activities including coordinating, requesting, tracking and processing of IQC data including: Baseline, on-going, and end/interim analysis IQC Data Review Coordination of cross calibration phantom rotation Phantom data analysis and data entry Ensuring accuracy of tracking information in IQC Tracking and study tracking databases as pertaining to IQC and/or DXA scanner information Coordinating machine change instances for appropriate documentation and equivalence data collection Machine Equivalence analysis and processing
- Ensure IQC data is collected and maintained according to applicable SOPs and/or study protocol requirements Manage Baseline, Interim and End of Study IQC data submissions, track and report progress to study teams and ensure timelines are met Communicate with Bioclinica clinical study team and/or sponsor regarding deliverables Understand functions of software used to produce and collect IQC data BMD Scan Review Form preparation Study database maintenance (e.g., change of contact information)
- Assists Project Managers with project administration by Planning and coordinating the site start-up activities Reading and understanding project protocol documents Entering, maintaining, and tracking of data in internal software Participating in project meetings, conference calls, and training calls Assists Project Managers in maintaining, reviewing and communicating project progress by Reviewing and analyzing project tracking weekly Generates, tracks and resolves data queries Identifying site and data trends, and recommending actions to Project Manager Communicating and following up on project tracking discrepancies
- Assisting in monitoring data flow Generating, reviewing and distributing weekly/monthly project tracking reports Ensures the development and adherence to project timelines as they relate to therapeutic processes by Following up on outstanding items including missing data, incomplete paperwork, etc.
- Managing site communication, including distribution of subject data reports Assisting in tracking and resolving of client issues Scheduling and tracking completion of site training Serving as additional point of contact to client, sites, sponsors, etc.
Regulatory Compliance Analyst
Smith & Nephew
09.2022 - 06.2023
- Mitigated potential legal liabilities by effectively managing compliance-related disputes and collaborating with external counsel as necessary.
- Supported the development of new products and services by assessing potential compliance risks and recommending appropriate controls.
- Reviewed company marketing materials for accuracy and adherence to regulatory guidelines, reducing instances of non-compliant communications.
Education
MBA - Project Management
Centro Europeo De Postgrado (CEUPE)
Madrid08.2024
Bachelor of Science - Nursing
University of Costa Rica
San Jose07.2022
Bachelor of Arts - English Language And Literature
University of Costa Rica
San Jose01.2016
Skills
- Ability to work in a team
- Problem-Solving
- Time Management
- Attention to Detail
- Problem-solving abilities
- Multitasking
- Organizational Skills
- Team Leadership
- Adaptability and Flexibility
- Decision-Making
- Task Prioritization
- Medical Terminology
- Interpersonal Skills
- Analytical Thinking
- Goal Setting
- Quality Control
- Quality Assurance
- Project Management
- Communication
- People skills
- Microsoft Office
- Critical Thinking
Certification
- Microsoft Excel Nivel I, UCR, 2022
- BLS, American Heart Association, 2020
- Norma ISO 13485 (Dispositivos Medicos), 2022
- Business Analytics I, UCENFOTEC, 2023
Areas Of Interest
- Research
- Medical Devices
- Farmacovigilance
- Public Health
- Education
- Administration
Languages
Spanish
Advanced
C1
English
Advanced
C1
French
Intermediate
B1
Personaldescription
I'm a nurse who dreams of working on research for the pharmaceutical industry whilst providing my knowledge in human care and life science to improve people's quality of life.
Personal Information
- ID Number: 1-16890216
- Gender: Feminine
Timeline
Clinical Data Manager
MSD
05.2024 - Current
Imaging Research Associate I
Clario
06.2023 - 05.2024
Regulatory Compliance Analyst
Smith & Nephew
09.2022 - 06.2023
- Microsoft Excel Nivel I, UCR, 2022
- BLS, American Heart Association, 2020
- Norma ISO 13485 (Dispositivos Medicos), 2022
- Business Analytics I, UCENFOTEC, 2023
MBA - Project Management
Centro Europeo De Postgrado (CEUPE)
Bachelor of Science - Nursing
University of Costa Rica
Bachelor of Arts - English Language And Literature
University of Costa Rica
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