Global Customer Operations Strategy & Experimentation Leader defining future operations and driving strategic planning with AI. Leading innovation in customer operations within LexisNexis.
About the role
- Oversee collection, analysis, and interpretation of clinical data to support regulatory submissions, post-market surveillance, and evidence generation
- Ensure data integrity and compliance with global regulatory standards (e.g., FDA, MDR, ISO 14155)
- Develop, maintain, and enforce SOPs and work instructions for clinical data management
- Design, develop, and manage clinical study databases in compliance with FDA regulations, QSR, and GCP
- Maintain clinical study hardware and software to support study execution
- Develop reporting strategies for interim and final clinical data analysis and establish reporting frameworks to monitor study performance
- Collaborate closely with Clinical Operations, Regulatory Affairs, and Biostatistics to align data management strategies with trial execution
- Provide guidance and mentorship to in-house and remote Clinical Data Management staff
- Build and maintain effective working relationships across Sonova group companies and provide global clinical data operations support
- Participate in resource forecasting and implement process improvements to enhance data management efficiency
- Stay current with industry trends and evolving regulatory requirements
- Support other Clinical Research Department functions and perform other duties as assigned
- Travel as required (up to 20%)
Requirements
- Bachelor’s Degree in a related field (e.g., Life Sciences, Data Science, Clinical Research)
- Nice to Have: Master’s degree in Life Sciences, Clinical Research, Data Science, or related field
- Extensive experience (5-7 years) in clinical data management, particularly in an FDA-regulated environment (Sponsor or Clinical Research Organization)
- Strong knowledge of electronic data capture (EDC) systems, clinical database development, and regulatory compliance (FDA, QSR, GCP)
- Experience designing, developing, and managing clinical study databases
- Experience maintaining clinical study hardware and software
- Nice to Have: Experience working with international regulatory frameworks (e.g., EMA, PMDA, Health Canada)
- Nice to Have: Prior exposure to medical device trials and post-market clinical follow-up (PMCF) studies
- Hands-on experience with advanced EDC and CTMS systems (e.g., Medidata Rave, Oracle Inform, Veeva)
- Understanding of risk-based monitoring (RBM) and centralized statistical monitoring
- Strong project management and organizational skills
- Ability to analyze engagement data and make data-driven decisions
- Nice to Have: Certification in Clinical Data Management, Project Management (PMP, PRINCE2), or Clinical Research (ACRP, SOCRA)
- Language: English - Fluent
- Nice to Have: German or Spanish
- IT Skills: Microsoft Office
- Experience with report development using MS-SQL, MS Access & any procedure or object-oriented programming languages
- Nice to Have: Familiarity with data visualization and analytics tools (e.g., Power BI, Tableau, Python, R)
- Minimum internet connectivity: 200Mb/sec download and 10Mb/sec upload
- Travelling Requirement: up to 20%
Benefits
- Medical, dental and vision coverage*
- Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
- TeleHealth options
- 401k plan with company match*
- Company paid life/ad&d insurance
- Additional supplemental life/ad&d coverage available
- Company paid Short/Long-Term Disability coverage (STD/LTD)
- STD LTD Buy-ups available
- Accident/Hospital Indemnity coverage
- Legal/ID Theft Assistance
- PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
- Paid parental bonding leave
- Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
- Robust Internal Career Growth opportunities
- Tuition reimbursement
- Hearing aid discount for employees and family
- Internal social recognition platform
- Hybrid work model / flexible working
- Bonus eligible
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