Embedded Pharma Clinical Project Manager

Cytel; Tallahassee (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Project Manager with pharmaceutical/clinical development experience. You will work embedded with a client, driving operational transformation, process optimizations, and vendor management during clinical development activities.

Responsibilities include coordinating data standards, organizing knowledge-transfer workshops, ensuring inspection readiness, and maintaining project documentation.

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 knowledge transfer workshops, documentation, training planning, and 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 build internal portals to support future activities.
• Support updates to SOPs as needed.
• Facilitate cross-functional project meetings and communicate status to internal teams and sponsor stakeholders.
• Present and explain methodology and consequences of decisions using strong communication skills.

Skills

Project management

Cross-functional leadership

Clinical development

Data management coordination

Communication skills

Documentation

Education

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

Tools

SDTM

ADaM

Statistical Programming

Job description

Cytel is seeking a Project Manager with pharmaceutical/clinical development experience. You will work embedded with a client, driving operational transformation, process optimizations, and vendor management during clinical development activities.

Responsibilities include coordinating data standards, organizing knowledge-transfer workshops, ensuring inspection readiness, and maintaining project documentation.