Clinical Data Manager - 8559 Job at Somewhere, Latin America

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  • Somewhere
  • Latin America

Job Description

POSITION OPEN FOR THE PHILIPPINES AND LATAM REGION

100% Remote

Position : Clinical Data Manager
Salary Range:Â $2500 - $3.500Â Usd based on experience
Type of Contract : Independent Contractor Agreement

POSITION OPEN FOR THE PHILIPPINES AND LATAM REGION

100% Remote

Position
: Clinical Data Manager
Salary Range: $2,000 to $3,000 Usd Based on Experience 
Type of Contract : Independent Contractor Agreement

The Clinical Data Manager is responsible for ensuring high-quality, accurate, and statistically sound data is generated from our clinical trials. The role changes at different stages of the trial and might include Case Report Form (CRF) designing, CRF annotation, UAT, setting data-entry guidelines, data validation, discrepancy management, data extraction, and database locking.
 
Minimum Requirements:
  • Bachelor's degree in relevant scientific discipline
  • At least 3 years of experience in data management roles
  • Proficiency in the use of various electronic data capture (EDC) systems preferred
  • TMF and/or ISF maintenance or support experience desirable
 
Roles and Responsibilities include:
  • Maintain data quality through prompt review of data entered in the EDC by site personnel and issuing, reviewing responses and closing out queries.
  • Supplementing automatic CRF edit checks with manual review of data for inconsistencies and omissions. Drafting or updating specifications and templates for reporting of the same.
  • Internal communication and escalation of project issues and collaboration for resolution.
  • Database lock support
  • Other tasks as assigned to support clinical trial execution and Reporting
  • Participate in quality assurance activities, including internal audits and inspections, to ensure compliance with regulatory requirements and adherence to quality standards
  • Documentation Management: Assist with maintaining accurate and up-to-date trial documentation, including trial master files (TMF), study files, and correspondence with investigative sites and regulatory authorities.
  • Ensure study compliance with Good Clinical Practice (GCP) guidelines, standard operating procedures (SOPs), and regulatory requirements throughout the conduct of clinical trials.

 

Job Tags

Contract work, For contractors, Remote work,

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