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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing operational activities for Externally Sponsored Research, ensuring compliance with regulatory standards and effective cross-functional collaboration. Proficient in developing metrics and analytics to drive efficiency and inform decision-making.
Highest-signal resume keywords
Clinical Operations ManagementProject ManagementRegulatory Compliance (GCP, ICH)Cross-Functional CollaborationStakeholder Management
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 Operational Activities ManagementMetrics DevelopmentData Integrity MaintenanceAudit ReadinessContracting and Regulatory Documentation
Soft Skills
Strong Verbal CommunicationStrong Written CommunicationAnalytical Problem-SolvingProactive Anticipation of ObstaclesCollaboration Skills
Tools & Technologies
ESR SystemsBusiness Analytics ToolsProject Management Software
Certifications & Qualifications
Bachelor's Degree in Life SciencesProject Management Professional (PMP)
Industry Keywords
Externally Sponsored ResearchInvestigator Sponsored StudiesPharmaceutical EnvironmentRegulated Medical EnvironmentCompliance Codes
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Manage overall study operational activities for Externally Sponsored Research from initial proposal submission to 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 program reporting
- Execute ESR process activities in compliance with 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 compliant and timely reviews of concepts, study outlines, protocols, and protocol amendments
- Develop metrics, KPIs, and business analytics to measure progress and inform investment decisions
- Collect, document, track, and communicate study updates to stakeholders
- Oversee the ESR system of record and maintain data integrity through standards, controls, and permissions
- Work with system vendors and Systems & Process Operations on issue resolution and enhancements
- Maintain product demand forecasts with Product Supply teams for adequate active-study supply
- Provide information for 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 related 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 such as 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 career growth through 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
- Equal opportunity and culturally inclusive workforce
