Project Manager FSP
- Canada
Full-time
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Job details
- Job type
- Full-time
- Posting language
- English
- Posted
Original job description
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.
Responsibilities
Your responsibilities will include but not limited to:
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:
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.
Responsibilities
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.
More about this job
Responsibilities
The Project Manager will coordinate clinical data standards and statistical programming activities while supporting operational transformation and process optimizations. They are responsible for maintaining project documentation, facilitating cross-functional meetings, and ensuring inspection readiness throughout the clinical development lifecycle.
Requirements
Candidates must hold a bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field. The role requires at least 5 years of experience in clinical research or pharmaceutical environments, including 2 years of project management experience.
Skills
- Project management
- Clinical development
- Statistical programming
- Data management
- Stakeholder management
- Process optimization
- Vendor management
- Clinical research
- SDTM
- ADaM
- TFLs
- Inspection readiness
- Cross-functional team coordination
- Communication skills
- Problem-solving
- Documentation maintenance
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Management & Leadership
- Science & Research
- Data & Analytics
- Consulting
Keywords
- Project Manager
- Clinical Development
- Pharmaceutical
- Statistical Programming
- Data Management
- SDTM
- ADaM
- TFLs
- ISS/ISE
- Clinical Operations
- Biostatistics
- SOPs
- Vendor Management
- Inspection Readiness
- Clinical Research
- Biotechnology
- Cross-functional Teams
- Process Optimization
- Documentation Maintenance
- Resource Forecasting
- Risk Logs
- Communication Plans
- Stakeholder Management
- Life Sciences
- Computer Science
- Data Ingestion
- Ad Hocs
- Operational Transformation
- Training Planning
- Project Plans