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site management coordinator resume example with 2+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Professional Summary
  • 3 years of experience in the pharmaceutical industry
    With experience in Pharmacovigilance (safety activities) of post marketing product.
  • In Clinical research I have experience in reception, management and reporting of clinical adverse events SAEs, submissions to the Regulatory authority of DSUR, SUSARs bimonthly reports, management of amendments to the Protocol, Investigator's Brochure, adaptation and customization of Informed Consent Forms (ICFs), management of systems and platforms, management of different TMFs.
  • Effective comunication, with ability to challenge and good interpersonal skills.
  • Knowledge in Local regulations, Adherence to Standard Operating Procedures (SOPs) and Work Instructions (WI)
  • Knowledge in international regulations of Central America and the Caribbean (CENCA) and Peru
  • Ability to work independently
  • Ability to manage multiple projects and priorizite task efectively
Skills
  • Excellent Communication
  • Analytical and Critical Thinking
  • Multitasking Abilities
  • Attention to Detail
  • Teamwork and Collaboration
  • Decision-Making
  • Training and Development
  • Critical Thinking
Education
El Bosque University 100 Montgomery St. 10th Floor, Expected in 03/2022 : Pharmaceutical Marketing Management Specialist - GPA :
Colegio Mayor De Cundinamarca University 100 Montgomery St. 10th Floor, Expected in 03/2019 Bachelor of Science : Medical Microbiology And Bacteriology - GPA :
Certifications

Certified Epidemiology and clinical research, El Rosario University Feb-May 2021


Certified Good Clinical Practices, El Rosario University Feb-May 2021


Diploma in Health Quality Management, Politecnico de Colombia, Jul-Aug 2021

Work History
Planet Pharma - Site Management Coordinator
Foster City, CA, 12/2021 - Current
  • Site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments.
  • Review of documents to verify that they are complete, consistent and accurate, under the direction of senior staff.
  • Prepare site regulatory documents, checking that they are complete and accurate.
  • Brief team members on finalization of regulatory and contractual documents for individual sites.
  • Distribution of completed documents to sites and internal project team members.
  • Support updating and maintaining internal systems, databases, tracking tools, schedules, and project plans with accurate and complete information on specific projects.
  • Review, track and monitor the progress, approval and execution of documents, regulatory documents, ethics, Informed Consent Form (ICF) and Investigator Packet (IP).
Alphanumeric On Behalf Janssen Pharmaceuticals - Medical Information Specialist
City, STATE, 04/2021 - 12/2021
  • Collected, organized and entered patient data into medical systems.
  • Retrieved medical data for physicians and patients.
  • Catalogued patient data in clinical databases and registries according to regulatory practices.
  • Performed regular quality and validation assessments on patient data to verify accuracy.
  • Secured confidential patient information from unauthorized access.
  • Conducted quality improvement and customer satisfaction surveys to evaluate patient care.
  • Worked flexible hours; night, weekend, and holiday shifts.
PRA Health Sciences - Safety Assistant II
City, STATE, 03/2020 - 03/2021
  • Gathered information, prepared reports, and drafted correspondence related to cases.
  • Provided assistance in managing health and safety programs aligned with industry standards.
  • Served as primary backup to officer in charge with various responsibilities related to compliance, operations management, and staff supervision.
  • Helped probation and pretrial services officers carry out investigation and supervision duties, providing assistance and technical support in variety of areas.
  • Knowledge of pre and post marketing pharmacovigilance regulation for the South American, Central American and Caribbean region.
  • Submission of periodic reports to the regulatory authority DSURs, SUSARs.
  • Reception of cases with serious adverse events (SAE) and non-serious adverse events (NSAE) related to research molecules, report to the regulatory authority of the corresponding country, always adhering to the legislation for each country
Analizar Laboratorio Clinico Automatizado - Bacteriologist
City, STATE, 08/2019 - 02/2020
  • Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
  • Carried out day-day-day duties accurately and efficiently.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Worked flexible hours; weekend, and holiday shifts
  • Collection of blood samples, gynecological and for genetic analysis
  • In charge of the request for the monthly order, attention to the audits carried out by the Ministry of Health and EPS and Prepaid Medicine with whom there was an agreement
Languages
Spanish :
Native or Bilingual
Negotiated :
English :
Professional Working
Negotiated :

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Resume Overview

School Attended

  • El Bosque University
  • Colegio Mayor De Cundinamarca University

Job Titles Held:

  • Site Management Coordinator
  • Medical Information Specialist
  • Safety Assistant II
  • Bacteriologist

Degrees

  • Bachelor of Science

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