Clinical Project Manager - Transformation Lead

Cytel; Topeka (KS); On-site; USD 85,000 - 115,000; Full time

Job summary

Cytel, in Topeka, seeks an experienced Project Manager to drive operational transformation within clinical development, coordinating data standards and vendor activities while maintaining documentation across programs.

You will lead cross-functional teams, manage timelines, risk logs, and communication plans, and support knowledge transfer and SOP updates to ensure inspection readiness and project success.

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.

Skills

Project management

Cross-functional teamwork

Clinical development

Statistical programming

Documentation control

Vendor management

Process optimization

Communication skills

Education

Bachelors in Life Sciences/Statistics/CS

Tools

SDTM

ADaM

SAS

Clinical data standards

Job description

Cytel, in Topeka, seeks an experienced Project Manager to drive operational transformation within clinical development, coordinating data standards and vendor activities while maintaining documentation across programs.

You will lead cross-functional teams, manage timelines, risk logs, and communication plans, and support knowledge transfer and SOP updates to ensure inspection readiness and project success.