Lead Clinical Data Manager, Trials & CDS

Pfizer

San Isidro

Hybrid

ARS 90,873,000 - 136,310,000

Full time

10 days ago

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Job summary

Pfizer in Buenos Aires, Argentina, is seeking a Lead Data Manager to oversee CDS activities across one or more clinical trials. You will design and test data collection tools, develop data management plans, review data quality, manage queries, and provide data access and visualization capabilities.

The role requires collaboration with study teams and ensuring TMF readiness. Minimum 3 years in data management, knowledge of GCP/FDA/ICH, and experience with EDC systems (Inform preferred) are

Qualifications

  • Understand clinical development process and GCP principles.
  • Experience with data management in clinical trials and regulatory standards.
  • Ability to interpret protocols and determine study requirements.
  • Strong communication, including remote collaboration.
  • Bachelor’s degree required; Master’s preferred.
  • Experience with FDA/ICH/GCP regulations and data standards.

Responsibilities

  • Lead daily data management activities for one or more trials.
  • Manage data acquisition standards, database design, and tooling.
  • Develop and maintain the Data Management Plan and TMF documents.
  • Perform data review, query management, and data visualization.
  • Coordinate milestones and ensure on-time delivery with quality.
  • Mentor junior data managers and perform peer reviews.
  • Collaborate with Clinical Data Scientist for CDS deliverables.
  • Ensure SOP compliance and cross-study knowledge sharing.
  • Drive continuous improvement in DM processes.

Skills

GCP knowledge
Data management
Clinical trials knowledge
Verbal and written communication
3+ years data management experience
Regulatory knowledge (FDA, ICH, GCP)
MS Office suite
Resource management
Team coaching/mentoring
Analytical problem solving

Education

Bachelor’s degree
Master’s degree

Tools

Inform
Spotfire
J-Review
TMF/eTMF documentation

Job description

Pfizer in Buenos Aires, Argentina, is seeking a Lead Data Manager to oversee CDS activities across one or more clinical trials. You will design and test data collection tools, develop data management plans, review data quality, manage queries, and provide data access and visualization capabilities.

The role requires collaboration with study teams and ensuring TMF readiness. Minimum 3 years in data management, knowledge of GCP/FDA/ICH, and experience with EDC systems (Inform preferred) are

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