Paula Coronado
Paula Coronado

Paula Coronado  new_releases

About

Detail

Senior Clinical Data Lead
Bogotá, Bogota, Colombia

Contact Paula regarding: 

work
Full-time jobs
Starting at USD130K/year
connect_without_contact
Finding mentors
Finding co-founders
groups
Networking

Timeline


work
Job
school
Education
2013
Today

Résumé


Jobs verified_user 0% verified
  • ICON plc
    Senior Clinical Data Lead
    ICON plc
    May 2023 - Current (2 years 1 month)
  • ICON plc
    Clinical Data Lead
    ICON plc
    Mar 2022 - Apr 2023 (1 year 2 months)

    • Point of Contact for day-to-day activities on a study with key responsibilities for study set-up and close out.
    • Overseeing and coordinating tasks delegated to study team members.
  • MSD
    Lead Clinical Data Manager
    MSD
    Dec 2021 - Mar 2022 (4 months)

    • As Global External Lead SME, I was accountable for authoring SOPs, exchanged document changes with Process Managers and Standard Process Owners and acted as POC for Global Data Operations.
    • Coordinated and delegated tasks to External Data SMEs located in Poland, China and Colombia.
    • Responsible for Oncology Trials business deliverables such as Data Base Locks (DBLs), Paper PI Signatures and Batch PI processes, First Site Ready (FSR), Early Permanent Site Closure (ESC) among others.
  • MSD
    Senior Clinical Data Manager
    MSD
    Mar 2021 - Nov 2021 (9 months)

    • Responsible for Data Validation Quality Assurance (QA), Quality Check (QC) and process adherence in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
    • Team coordination, CDMs/Sites training and mentoring for high priority protocols.
    • Global status tracking, metrics preparation and issue resolution at program level.
    • Trial level archiving activities including filing of essential documentation.
  • MSD
    Clinical Data Manager
    MSD
    Nov 2019 - Feb 2021 (1 year 4 months)

    • Lead external data reconciliation and vendor oversight in a breast mega-trial (1140 patients enrolled).
    • Effective communication liason between Trial Managers, Clinical and Safety Scientists, Statisticians, Vendors and Data Management.
    • Execute data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation.
  • C
    Junior Project Manager Intern in Biotechnology
    Center for Cell Therapy and Physiological Regulation Medicine - Dr. Felipe Torres Organization
    Jan 2018 - Jun 2018 (6 months)

    • Charged of market study, cost estimating, analysis and project risks for the implementation of a functional magnetic resonator.
    • Evaluated and designed a protocol for the implementation of biopsychology paradigms and image post-processing softwares.
    • Communication liaison between neurologists, radio neurologists and radiologists for internal co-work meetings.
  • A
    Private Tutor
    Apoyo Académico Personalizado (A.A.P)
    Jul 2017 - Nov 2019 (2 years 5 months)

    • Provided support and tools to successfully achieve courses in Mathematics, Physics, Chemistry and Biology, for primary and secondary students who are preparing the French Secondary School Diploma (Baccalauréat).
    • Effective test-taking strategies.
  • A
    Research Assistant at the BioInformatics Institute (BII)
    A*STAR
    Dec 2016 - Jun 2017 (7 months)

    • Worked on 3D and 4D biological image processing and cell tracking in collaboration with the Singapore Image and Pervasive Access Lab (IPAL).
    • Set up a cell filtering and segmentation tutorial in ImageJ (Java-based image processing program developed at the National Institutes of Health) to be used by interns at BII.
  • M
    Private Tutor
    Mariño Maths
    Sep 2016 - Nov 2016 (3 months)

    • Homework math tutoring for high school students who are preparing to pass the French High School Diploma (Baccalauréat) of the Lycée Francais Louis Pasteur.
Education verified_user 0% verified
  • Universidad el Bosque
    Bachelor of BioEngineering
    Universidad el Bosque
    Jul 2013 - Jan 2019 (5 years 7 months)