Senior Project Manager, French Speaking

• Lead and/or oversee regional and global PA-NPP or related projects, ensuring project timelines are met as per contract
• Develop, maintain, and ensure compliance of project plans, timelines, and budgets with the Scope of Work
• Lead, train, and provide operational oversight to project teams
• Oversee delegation of support staff activities and potentially line-manage direct reports
• Build and maintain positive client relationships
• Communicate with clients to maintain operational processes and deliver projects within scope
• Identify, evaluate, monitor, and mitigate project quality risks
• Communicate risks to internal teams, upper-level management, and clients as appropriate
• Develop and document study-specific training requirements
• Prepare and finalize Out of Scopes and develop change orders with Business Development
• Ensure project teams manage programs according to WEP Clinical SOPs and Policies
• Participate in proposal meetings for potential clients
• Review Electronic Trial Master File documentation, including treatment guidelines, protocols, case report forms, informed consent documents, investigator agreements, brochures, logic checks, and data handling guidelines
• Assist management with developing, documenting, and updating internal procedures, SOPs, working practices, and quality assurance forms
• Provide operational oversight during programs and projects
• Review site visit preparation documents, site visit reports, and site payments
• Audit eTMF and CTMS compilation and completion
• Maintain current knowledge of FDA, GDPR, global regulations, and GCP/ICH Guidelines for PA-NPP and clinical research

• Fluency in French is a requirement for this role
• Bachelor's Degree (in a health or science field preferred)
• Significant experience and demonstrated ability in project management or clinical research, with direct clinical trial or PA-NPP experience in a CRO or research-related organization
• Computer literacy and proficiency in Microsoft Office
• Experience with an eTMF and CTMS
• Understanding of basic data processing functions, including electronic data capture
• Ability to handle confidential information with complete discretion
• Strong organizational, interpersonal, and attention-to-detail skills
• Ability to manage multiple priorities and interact with all levels of staff to coordinate and execute study activities
• Effective verbal and written communication skills, including the ability to express complex ideas
• Knowledge of the clinical development process from Phase I through regulatory submission
• Working knowledge of current ICH GCP guidelines
• Ability to reason independently to assess and recommend specific solutions in clinical settings
• Ability to set baseline targets, track trends, and implement mitigation plans
• Resume must be submitted in English

Demonstrates expertise in project management and clinical research, with a strong focus on compliance with FDA, GDPR, and GCP/ICH guidelines. Proficient in managing project timelines, budgets, and client relationships while ensuring quality and operational oversight.

• Project Management
• Clinical Research Experience
• Fluency in French
• ETMF and CTMS Proficiency
• Knowledge of ICH GCP Guidelines

• Project Management
• Clinical Trial Management
• Data Processing Functions
• Budget Management
• Quality Risk Mitigation
• Regulatory Compliance
• Study-Specific Training Development
• Change Order Development
• Electronic Data Capture
• Documentation Review

• Organizational Skills
• Interpersonal Skills
• Attention to Detail
• Effective Communication
• Ability to Manage Multiple Priorities

• FDA Regulations
• GDPR Compliance
• GCP Guidelines
• Clinical Development Process
• PA-NPP

• Microsoft Office
• ETMF
• CTMS