Clinical Project Manager, Client-Embedded Pharma

Cytel; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Cytel is seeking a Project Manager in Indianapolis with extensive clinical development experience to lead cross-functional teams and drive operational transformation for sponsor projects. You will coordinate data standards, manage timelines, and ensure robust documentation while advancing SOPs and process improvements in a fast-paced pharmaceutical environment.

This fully embedded, sponsor-dedicated role offers the backing of Cytel, a collaborative culture, and opportunities to influence the

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.

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

Leadership

Communication

Stakeholder Management

Problem Solving

Education

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

Job description

Cytel is seeking a Project Manager in Indianapolis with extensive clinical development experience to lead cross-functional teams and drive operational transformation for sponsor projects. You will coordinate data standards, manage timelines, and ensure robust documentation while advancing SOPs and process improvements in a fast-paced pharmaceutical environment.

This fully embedded, sponsor-dedicated role offers the backing of Cytel, a collaborative culture, and opportunities to influence the