Responsible for overseeing the collection, analysis, and interpretation of clinical data to support regulatory submissions, post-market surveillance, and evidence generation
Ensures data integrity, compliance with global regulatory standards (e.g., FDA, MDR, ISO 14155), and alignment with clinical research objectives
Collaborates with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to translate complex clinical data into actionable insights that drive product development, market adoption, and patient safety
Develop, maintain, and enforce standard operating procedures (SOPs) and work instructions for clinical data management
Design, develop, and manage clinical study databases in compliance with FDA regulations, Quality System Regulations (QSR), and Good Clinical Practices (GCP)
Maintain clinical study hardware and software to support study execution
Develop reporting strategies for interim and final clinical data analysis
Establish reporting frameworks to monitor operational study performance and ensure data consistency across studies
Work closely with Clinical Operations to align data management strategies with overall trial execution
Provide guidance and mentorship to in-house and remote Clinical Data Management staff
Foster a collaborative team environment and provide leadership to support high-quality data collection and analysis
Build and maintain effective working relationships with other group companies in Sonova, to include providing support and guidance with respect to global clinical data operations
Participate in resource forecasting and implement process improvements to enhance data management efficiency
Stay current with industry trends and evolving regulatory requirements to ensure best practices
Support other Clinical Research Department functions as needed to achieve department goals
Other duties as assigned by your manager
Travelling Requirement: up to 20%

Requirements

Bachelor’s Degree in a related field (e.g., Life Sciences, Data Science, Clinical Research)
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
Prior experience working with international regulatory frameworks (e.g., EMA, PMDA, Health Canada) preferred
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, with the ability to manage multiple initiatives simultaneously
Ability to analyze engagement data and make data-driven decisions to enhance employee experience
Certification in Clinical Data Management, Project Management (PMP, PRINCE2), or Clinical Research (ACRP, SOCRA) preferred
Experience with report development using MS-SQL, MS Access & any procedure or object-oriented programming languages desirable
Familiarity with data visualization and analytics tools (e.g., Power BI, Tableau, Python, R)

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*

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical data managementelectronic data capture (EDC)clinical database developmentregulatory compliancereport developmentdata analysisrisk-based monitoring (RBM)data visualizationprogramming languagesproject management

Soft skills

leadershipcollaborationorganizational skillsmentorshipcommunicationdata-driven decision makingprocess improvementteam environmentresource forecastingmulti-initiative management

Certifications

Clinical Data ManagementProject Management Professional (PMP)PRINCE2Clinical Research Associate (ACRP)Society of Clinical Research Associates (SOCRA)