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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Externally Sponsored Research activities, ensuring compliance with regulatory standards such as GCP and ICH, while effectively collaborating with diverse stakeholders and maintaining data integrity in research operations.
Highest-signal resume keywords
Clinical Operations ExperienceProject Management CertificationRegulatory Compliance KnowledgeCross-Functional CollaborationAnalytical Problem-Solving Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study ManagementRegulatory DocumentationMetrics DevelopmentData Integrity MaintenanceProcess Efficiency ImprovementAudit ReadinessSupply Chain ManagementContract ManagementPerformance TrackingStakeholder Communication
Soft Skills
Strong Verbal CommunicationStrong Written CommunicationProactive Problem AnticipationIndependent Work CapabilityCollaboration Skills
Tools & Technologies
ESR SystemsData Management ToolsProject Management SoftwareAnalytical Tools
Certifications & Qualifications
Bachelor's Degree in Life SciencesProject Management Professional (PMP)
Industry Keywords
Externally Sponsored ResearchInvestigator Sponsored StudiesGCPICH StandardsRegulated Medical EnvironmentPharmaceutical IndustryClinical TrialsAudit ComplianceStakeholder ManagementCross-GBU Initiatives
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Manage overall study operational activities for Externally Sponsored Research from proposal submission through study closeout
- Manage Scientific Review Committee activities and track ESR performance
- Manage supply, contracting, regulatory documentation, cross-reference letters, transfer of value reporting, payments, and ESR program reporting
- Execute ESR process activities compliantly according to Sanofi SOPs, policies, procedures, and local laws and regulations
- Contribute to audit readiness and respond accurately and rapidly to audit inquiries
- Collaborate cross-functionally on research agreements, product supply, purchase orders, and other deliverables
- Support Scientific Review Committee reviews of concepts, study outlines, protocols, and protocol amendments
- Support development of metrics, KPIs, and business analytics
- Collect, document, track, and communicate study updates to stakeholders
- Oversee the ESR system of record and maintain data integrity
- Work with system vendors and Systems & Process Operations on issue resolution and enhancements
- Maintain product demand forecasts with Product Supply teams
- Support CMO reporting and cross-GBU ESR initiatives
- Support dissemination of safety updates and Dear Investigator Letters
- Ensure stakeholders are trained and have access to ESR systems and tools
Requirements
What you’ll need- Bachelor's degree in life sciences or a related scientific discipline
- Minimum 2 years of relevant experience in clinical operations, hospital settings, pharmaceutical, or another regulated medical environment
- Project management experience; certification (e.g., PMP) is a plus
- Familiarity with Investigator Sponsored Studies program requirements and the external regulatory environment, including GCP, ICH standards, and compliance codes
- Proven track record of driving efficiency in processes
- Ability to proactively anticipate obstacles and work independently with minimal direction
- Experience managing diverse stakeholders across different functions and seniority levels
- Strong verbal and written communication skills
- Strong quantitative, analytical, and problem-solving skills
- Proven cross-functional collaboration skills across multiple teams and seniority levels
Benefits
Comp & perks- Opportunities for promotion or lateral moves, at home or internationally
- Rewards package recognizing contribution and impact
- Health and wellbeing benefits
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Employee benefit programs
- Opportunities to work with cutting-edge AI, data, and digital platforms
