Pharma Project Manager - Clinical Development Lead

Cytel

San Juan (PR)

On-site

USD 100,000 - 140,000

Full time

4 days ago
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Job summary

Cytel is seeking a Project Manager with experience in pharmaceutical and clinical development to lead cross-functional teams embedded with a global client. You will motivate teams, drive process improvements, and ensure client satisfaction.

Responsibilities include coordinating clinical data standards, supporting SOP updates, organizing knowledge transfer, maintaining documentation, and communicating project status to sponsors.

Qualifications

  • Bachelor’s degree in Life Sciences, Statistics, Computer Science, or a related field.
  • 5+ years of experience in clinical research, CRO, pharmaceutical, or biotechnology environments.
  • 2+ years of project management or study management experience.
  • Working knowledge of the clinical development lifecycle.
  • Deep understanding of Clinical/Statistical Programming (Data ingestion, SDTM, ADaM, TFLs, Ad Hocs, ISS/ISE, etc.)
  • Understanding of the relationship between source/clinical data, SDTM datasets, ADaM datasets, tables, listings, and figures.
  • Experience coordinating cross-functional teams, including Data Management, Biostatistics, Statistical Programming, and Clinical Operations.
  • Strong organizational, communication, stakeholder management, and problem-solving skills.

Responsibilities

  • Coordinate and track clinical data standards and statistical programming activities across clinical programs.
  • Support operational transition activities including organizing workshops for knowledge transfer, identifying/maintaining procedural documents, training planning and creating checklist and documentation inventory.
  • Support inspection readiness and ensure appropriate project documentation is maintained.
  • Develop and maintain task lists, process flow, project plans, timelines, resource forecasts, risk logs, and communication plans.
  • Help to build internal portal to support future activities.
  • Support to update SOPs as needed.
  • Facilitate cross-functional project meetings and communicate project status to internal teams and sponsor stakeholders.
  • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.

Skills

Cross-functional leadership
Clinical data standards
Project coordination
Client communication

Education

Bachelor’s degree in Life Sciences

Tools

Clinical/Statistical Programming

Job description

Cytel is seeking a Project Manager with experience in pharmaceutical and clinical development to lead cross-functional teams embedded with a global client. You will motivate teams, drive process improvements, and ensure client satisfaction.

Responsibilities include coordinating clinical data standards, supporting SOP updates, organizing knowledge transfer, maintaining documentation, and communicating project status to sponsors.

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