Pharma Clinical Project Manager, Cross-Functional Leader

Cytel

Austin (TX)

On-site

USD 80,000 - 110,000

Full time

11 days ago
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Job summary

Cytel is seeking a Project Manager to join a sponsor-dedicated program in Austin, TX. You will coordinate cross-functional teams and manage timelines, driving process improvements in pharmaceutical and biotech settings.

You will collaborate with Data Management, Biostatistics and Clinical Operations, overseeing documentation, training, and vendor interactions while reporting progress to sponsors. A life sciences degree and 5+ years in clinical research are expected.

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 workshop 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.]
  • Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

Skills

Cross-functional coordination
Project management
Communication
Stakeholder management
Problem solving
Clinical data knowledge

Education

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

Job description

Cytel is seeking a Project Manager to join a sponsor-dedicated program in Austin, TX. You will coordinate cross-functional teams and manage timelines, driving process improvements in pharmaceutical and biotech settings.

You will collaborate with Data Management, Biostatistics and Clinical Operations, overseeing documentation, training, and vendor interactions while reporting progress to sponsors. A life sciences degree and 5+ years in clinical research are expected.

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