Strategic Clinical Project Lead – Pharma

Cytel; Lansing (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Project Manager to lead cross-functional teams in clinical development. You will coordinate data standards and programming across programs, while ensuring documentation and transition activities run smoothly.

Your role focuses on process improvements, vendor management, and maintaining inspection readiness for sponsor projects in a fully embedded, sponsor-dedicated environment.

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 coordination

Communication skills

Organizational skills

Problem-solving

Education

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

Job description

Cytel is seeking a Project Manager to lead cross-functional teams in clinical development. You will coordinate data standards and programming across programs, while ensuring documentation and transition activities run smoothly.

Your role focuses on process improvements, vendor management, and maintaining inspection readiness for sponsor projects in a fully embedded, sponsor-dedicated environment.