Clinical Project Manager - Lead Cross-Functional Drug Dev

Cytel; Helena (MT); On-site; USD 90,000 - 140,000; Full time

Job summary

Cytel is seeking a Project Manager with experience in pharmaceutical and clinical development to join our sponsor-dedicated program in Helena, MT. You’ll manage cross-functional teams and support client on operational transformation, process optimization, and vendor management during clinical development activities.

You will coordinate data standards, documentation, inspections readiness, and planning, while building processes, timelines, risk logs, and communication plans.

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 transition activities including knowledge transfer workshops, documenting procedures, and training planning
• Support inspection readiness and ensure appropriate project documentation is maintained
• Develop and maintain task lists, process flows, 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

Cross-functional coordination

Project management

Communication

Stakeholder management

Problem solving

Clinical/Statistical Programming

Education

Bachelor's degree in Life Sciences, Statistics, Computer Science, or a 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, etc.)

Understanding of source/clinical data relationships (SDTM/ADaM, TFLs, IVE)

Experience coordinating cross-functional teams (Data Management, Biostatistics, Programming, Clinical Ops)

Strong organizational, communication, stakeholder management, and problem-solving skills

Tools

Statistical Programming

Job description

Cytel is seeking a Project Manager with experience in pharmaceutical and clinical development to join our sponsor-dedicated program in Helena, MT. You’ll manage cross-functional teams and support client on operational transformation, process optimization, and vendor management during clinical development activities.

You will coordinate data standards, documentation, inspections readiness, and planning, while building processes, timelines, risk logs, and communication plans.