Strategic Clinical Development Project Manager

Cytel; Salem (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Project Manager to join a sponsor-dedicated program in the pharmaceutical/clinical development space. You will lead cross-functional teams, drive operational transformation, and manage data standards, documentation, and process improvements across clinical programs.

You will coordinate data standards, support transfer workshops, ensure inspection readiness, and maintain project plans, risk logs, and communications across sponsor stakeholders.

Qualifications

• 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 workshops for knowledge transfer, identifying/maintaining procedural documents, training planning and creating checklists 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.
• 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 collaboration

Communication

Stakeholder management

Problem solving

Organization

Education

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

Job description

Cytel is seeking a Project Manager to join a sponsor-dedicated program in the pharmaceutical/clinical development space. You will lead cross-functional teams, drive operational transformation, and manage data standards, documentation, and process improvements across clinical programs.

You will coordinate data standards, support transfer workshops, ensure inspection readiness, and maintain project plans, risk logs, and communications across sponsor stakeholders.