Clinical Project Manager: Data-Driven Ops & Study Lead

Cytel; Montpelier (VT); On-site; USD 90,000 - 140,000; Full time

Job summary

Cytel is seeking a Project Manager to join a sponsor-dedicated program embedded with a pharmaceutical client. You will drive operational transformation, coordinate cross-functional teams, manage vendor relationships, and maintain documentation throughout clinical development activities.

You will build and maintain project plans, timelines, risk logs, and communications, lead meetings, and present status to sponsors.

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 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

Communication

Stakeholder management

Cross-functional coordination

Problem solving

Education

Bachelor's degree in Life Sciences/Statistics/Computer Science

Job description

Cytel is seeking a Project Manager to join a sponsor-dedicated program embedded with a pharmaceutical client. You will drive operational transformation, coordinate cross-functional teams, manage vendor relationships, and maintain documentation throughout clinical development activities.

You will build and maintain project plans, timelines, risk logs, and communications, lead meetings, and present status to sponsors.