Clinical Development Program Manager

Cytel; Augusta (ME); On-site; USD 100,000 - 140,000; Full time

Job summary

Cytel is seeking a Project Manager to drive operational transformation in a pharmaceutical/clinical development setting. You will partner with cross-functional teams and sponsor stakeholders to optimize processes, manage vendors, and maintain documentation during clinical activities.

You will lead data standards coordination, ensure inspection readiness, and develop project plans, timelines, and risk logs. A strong communicator with 5+ years in the field will thrive here.

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 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

Project management

Communication

Vendor management

Documentation

Problem solving

Organizational skills

Client collaboration

Education

Bachelor's degree in Life Sciences/Statistics/CS or related field

Tools

SDTM

ADaM

TFLs

ISS/ISE

Job description

Cytel is seeking a Project Manager to drive operational transformation in a pharmaceutical/clinical development setting. You will partner with cross-functional teams and sponsor stakeholders to optimize processes, manage vendors, and maintain documentation during clinical activities.

You will lead data standards coordination, ensure inspection readiness, and develop project plans, timelines, and risk logs. A strong communicator with 5+ years in the field will thrive here.