Clinical Data Specialist: Global Trial Expert

hace 2 días


San José, San José, Costa Rica Saj Fortrea Costa Rica Srl A tiempo completo

Job Summary

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We are seeking a skilled Clinical Data Specialist to join our team in Costa Rica. This role will involve reviewing clinical trial data, generating and resolving queries, and collaborating with external vendors.

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About the Company

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Saj Fortrea Costa Rica Srl is a leading contract research organization (CRO) with a strong commitment to scientific rigor and decades of experience in clinical development. We provide a wide range of services to pharmaceutical, biotechnology, and medical device companies across various therapeutic areas.

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Job Responsibilities

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  • Review clinical trial data according to [Global] Data Management Plans and applicable standardized data management processes\
  • Generate, resolve, and track queries to address problematic data identified during data review activities\
  • Perform aggregate review of clinical data by patient, site, and/or project to identify data trends and inconsistencies that require further investigation\
  • Apply quality control procedures and checks to ensure data quality standards are achieved\
  • Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF completion guidelines), and Data Management Plans\
  • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that deliver accurate, timely, consistent, and quality clinical data\
  • Collaborate with external vendor and sponsor counterparts for study expectations, including milestones, deliverable timelines, communication expectations, etc.\\$
  • Ensure electronic external vendor data transfers contain all protocol specified parameters, are in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent\\$
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Requirements

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To be successful in this role, you should have:

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  • A university/college degree in life sciences, health sciences, or a related subject\
  • 1-3 years of experience working on Clinical Data Management or with Clinical Trial protocols\
  • Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations\
  • Time management skill and ability to adhere to project productivity metrics and timelines\
  • Ability to work in a team environment and collaborate with peers\
  • Good organizational ability, communication, and interpersonal skills\
  • Team working skills and good collaborator skills\\$
  • Knowledge of medical terminology is preferred\\$
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Benefits

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We offer a competitive salary of $60,000 - $80,000 per annum, depending on experience, plus benefits.

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Contact Information


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