Clinical Project Manager - Pharma Data & Ops Lead

Cytel; Denver (CO); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Job summary

Cytel is seeking a Project Manager for a sponsor-dedicated role in Denver, integrating with a pharmaceutical client to drive operational transformation and process optimization in clinical development.

You will coordinate cross-functional teams, manage documentation, and ensure quality across SDTM/ADaM data, tables, listings, and figures, while developing plans and communicating progress to stakeholders.

Qualifications

• Bachelor's degree in Life Sciences, Statistics, Computer Science, or 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 programming activities across programs.
• Support operational transition activities including workshops, knowledge transfer, and documentation inventories.
• Support inspection readiness and ensure project documentation is maintained.
• Develop and maintain task lists, process flows, project plans, timelines, resource forecasts, risk logs, and communication plans.
• Help build internal portal to support future activities.
• Update SOPs as needed.
• Facilitate cross-functional project meetings and report status to stakeholders.
• Present methodology and decisions clearly to sponsor teams.

Skills

Project management

Cross-functional coordination

Strong communication

Stakeholder management

Problem solving

Organizational skills

Education

Bachelor's degree in Life Sciences

Job description

Cytel is seeking a Project Manager for a sponsor-dedicated role in Denver, integrating with a pharmaceutical client to drive operational transformation and process optimization in clinical development.

You will coordinate cross-functional teams, manage documentation, and ensure quality across SDTM/ADaM data, tables, listings, and figures, while developing plans and communicating progress to stakeholders.