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Senior Project Manager, French Speaking
WEP ClinicalSenior Project Manager leading French-speaking Post Approval Named Patient Programs at WEP Clinical, a clinical research services provider. Managing timelines, budgets, teams, clients, risks, and regulatory compliance.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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.
Highest-signal resume keywords
Project ManagementClinical Research ExperienceFluency in FrenchETMF and CTMS ProficiencyKnowledge of ICH GCP Guidelines
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementClinical Trial ManagementData Processing FunctionsBudget ManagementQuality Risk MitigationRegulatory ComplianceStudy-Specific Training DevelopmentChange Order DevelopmentElectronic Data CaptureDocumentation Review
Soft Skills
Organizational SkillsInterpersonal SkillsAttention to DetailEffective CommunicationAbility to Manage Multiple Priorities
Tools & Technologies
Microsoft OfficeETMFCTMS
Industry Keywords
FDA RegulationsGDPR ComplianceGCP GuidelinesClinical Development ProcessPA-NPP
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Group Private Medical Insurance
- Group General Life Assurance
- Group Critical Illness and Group Income Protection
- Salary sacrifice pension scheme
- Enhanced maternity & paternity pay
- Educational Assistance allowance
- Paid volunteering day
- Wellness, growth, development, and team relationship initiatives
- Team events
- Inclusive, supportive work environment