Project Manager FSP

Cytel • United States,

17d • Onsite

About The Position

As a Project Manager, you’ll work with cross-functional teams and support clients on operational transformation, process optimizations, vendor management, as well as documentation maintenance during clinical development activities. You will be working fully embedded within one of our pharmaceutical clients, at the heart of their innovation. This role is dedicated to one of our global pharmaceutical clients who are driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Requirements

• 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 checklists 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level