Clinical Data Manager

hace 2 semanas

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

Job Description:

Position Overview:

Under the direction of the applicable management, the Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our company Standard Operating Procedures and guidelines.


Primary activities include but are not limited to:

  • Performs Sponsor Data Entry & Executes data validation activities in accordance with relevant Standard Operating Procedures.
  • Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities
  • Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
  • Responsible for the execution of user acceptance testing of data management tools under the guidance of the Senior Clinical Data Manager/Lead Clinical Data Manager. Escalates overdue items, including but not limited to outstanding questions and missing visits.
  • Assists the Senior/Lead Clinical Data Manager with data management activities to resolve all identified data issues prior to study database lock.
  • Completes trial level archiving activities under the direction of the Senior Clinical Data Manager/Lead Clinical Data Manager including, but not limited to, filing of essential documentation.
  • Reviews Essential Documents Compliance across the portfolio to ensure correct archival of required documentation, management of deviations/exceptions and UNB incidents.

Search Firm Representatives Please Read Carefully

Employee Status:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R224294

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