Note: The job is a remote job and is open to candidates in USA. Cytel is seeking a Project Manager to support a sponsor-dedicated pharmaceutical client. The role coordinates clinical data standards and statistical programming activities, manages operational transformation and documentation, supports inspection readiness, and facilitates cross-functional communication during clinical development.
Responsibilities
- Coordinate and track clinical data standards and statistical programming activities across clinical programs
- Support operational transition activities including organizing workshop 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
- 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
Benefits
- Full-time employment
- Consistent training, development and support
Company Overview
Company H1B Sponsorship