Clinical Project Manager: Transformation & Cross-Functional Leader

Cytel; Lincoln (NE); On-site; USD 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Project Manager to lead clinical data standards coordination and cross-functional programming activities within sponsor-dedicated projects. You will drive operational transformation and documentation maintenance, ensuring timely delivery across clinical programs.

The role requires 5+ years in clinical research or pharma settings, with strong communication and project management skills. You will collaborate with Data Management, Biostatistics, and Clinical Operations, in a

Qualifications

• Bachelor's degree in Life Sciences, Statistics, Computer Science, or related field.
• 5+ years of 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).
• Understanding 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

Project management

Cross-functional

Client communication

SDTM/ADaM

Statistical programming

Documentation

Vendor management

Time management

Education

Bachelor's degree in Life Sciences/Statistics/CS

Job description

Cytel is seeking a Project Manager to lead clinical data standards coordination and cross-functional programming activities within sponsor-dedicated projects. You will drive operational transformation and documentation maintenance, ensuring timely delivery across clinical programs.

The role requires 5+ years in clinical research or pharma settings, with strong communication and project management skills. You will collaborate with Data Management, Biostatistics, and Clinical Operations, in a