Clinical Development Project Manager — Pharma Sponsor

Cytel

Baton Rouge (LA)

On-site

USD 110,000 - 140,000

Full time

4 days ago
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Job summary

Cytel Inc. in Baton Rouge, LA is seeking a Project Manager with pharmaceutical and clinical development experience to lead cross-functional teams, drive process improvements, and ensure sponsor satisfaction on a dedicated program.

You will coordinate data standards, programming activities, vendor management, and documentation across clinical programs, while maintaining project plans, risk logs, and timelines. The role emphasizes collaboration, communication, and rigorous documentation.

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 programming activities across clinical programs.
  • Support operational transition activities including workshops for knowledge transfer, documentation inventory, and training planning.
  • Support inspection readiness and ensure project documentation is maintained.
  • Develop and maintain task lists, process flows, project plans, timelines, resource forecasts, and risk logs.
  • Help build internal portals to support future activities.
  • Assist in updating SOPs as needed.
  • Facilitate cross-functional project meetings and communicate status to sponsor stakeholders.
  • Present and explain methodology and decisions to stakeholders.

Skills

Project management
Cross-functional coordination
Communication
Stakeholder management
Problem solving
Organizational skills

Education

Bachelor's degree in Life Sciences/Statistics/Computer Science or related field

Tools

SDTM
ADaM

Job description

Cytel Inc. in Baton Rouge, LA is seeking a Project Manager with pharmaceutical and clinical development experience to lead cross-functional teams, drive process improvements, and ensure sponsor satisfaction on a dedicated program.

You will coordinate data standards, programming activities, vendor management, and documentation across clinical programs, while maintaining project plans, risk logs, and timelines. The role emphasizes collaboration, communication, and rigorous documentation.

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