Project Manager FSP

Cytel; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Cytel Inc. is seeking a Project Manager with experience in pharmaceutical and clinical development to join a sponsor-dedicated program.

You will work embedded with a global client, drive operational transformation, and coordinate cross-functional teams across Data Management, Biostatistics, and Clinical Operations. You will develop project plans, timelines, risk logs and communications, support knowledge transfer activities, and ensure inspection readiness.

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.)

Responsibilities

• Coordinate and track clinical data standards and statistical programming activities across clinical programs.
• Support operational transition activities including workshops for knowledge transfer, documentation, training planning and inventories.
• Support inspection readiness and ensure project documentation is maintained.
• Develop and maintain task lists, process flow, project plans, timelines, resource forecasts, risk logs, and communication plans.
• Help build internal portal to support future activities.
• Update SOPs as needed.
• Facilitate cross-functional project meetings and communicate status to internal teams and sponsor stakeholders.
• Present methodology and decisions to stakeholders using strong communication skills.

Skills

Project management

Communication skills

Stakeholder management

Problem-solving

Education

Bachelor's degree in Life Sciences, Statistics, Computer Science, or related field

Tools

SDTM

ADaM

Statistical Programming

Job description

Who Are You?

A Project Manager with experience working in pharmaceutical and clinical development environment. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Project Manager you will be dedicated to one of our global pharmaceutical clients; a company that is 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.

Position Overview:

As a Project Manager, you’ll work with cross-functional teams and support client on operational transformation, process optimizations, vendor management as well as documentation maintenance during clinical development activities.

Your responsibilities will include but not limited to:

• 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

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• 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

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.