Clinical Systems Manager, Clinical Data Management
Rapport Therapeutics
Summary
As Clinical Systems Manager you will oversee the implementation, maintenance, optimization, and security of clinical information systems (such as EDC, Data Warehousing and Reporting Tools, IRT, or eCOA) to ensure they support safe, efficient, and compliant clinical research.
Job description
Your impact
As Clinical Systems Manager you will oversee the implementation, maintenance, optimization, and security of clinical information systems (such as EDC, Data Warehousing and Reporting Tools, IRT, or eCOA) to ensure they support safe, efficient, and compliant clinical research.
Your day-to-day
- System Administration: Manage the deployment, daily operations, upgrades, and configuration of clinical platforms.
- Cross-Functional Liaison: Serve as the primary bridge between clinical end-users (doctors, nurses, researchers) and IT or software development vendors.
- Integration & Data Flow: Oversee system interfaces (such as HL7/FHIR or lab/radiology connections) to ensure data moves accurately between platforms.
- Compliance & Validation: Maintain adherence to regulatory standards like HIPAA, GCP, 21 CFR Part 11, and data privacy rules.
- User Training & Support: Coordinate testing, write Standard Operating Procedures (SOPs), and guide staff on proper system usage.
- Vendor & Project Management: Oversee third-party software providers, track project milestones, and manage system changes.
- Serve as a trusted business partner across Data Management, Biostatistics, Programming, Clinical Operations, Finance, and Clinical Development, fostering cross-functional collaboration and continuous improvement.
Must-Haves
- Bachelor's degree in Computer Science, Information Systems, Nursing, Life Sciences, or a related field.
- 4 to 7 years of combined experience in healthcare, clinical development, or IT data management, including 2+ years in a leadership or system ownership role.
- Proficiency with Electronic Health Record (EHR) systems, database structures (SQL), SAS, cloud environments (AWS/GCP), and data integration standards. CDASH, SDTM, data quality standards and submission requirements
- Strong analytical, organizational, and problem-solving skills with attention to detail.
- Excellent communication and leadership skills with the ability to influence across functions and levels.
Requirements
- Bachelor's degree in Computer Science, Information Systems, Nursing, Life Sciences, or a related field
- 4 to 7 years of combined experience in healthcare, clinical development, or IT data management
- 2+ years in a leadership or system ownership role
- Proficiency with Electronic Health Record (EHR) systems
- Proficiency with database structures (SQL)
- Proficiency with SAS
- Proficiency with cloud environments (AWS/GCP)
- Proficiency with data integration standards
- Knowledge of CDASH, SDTM, data quality standards and submission requirements
- Strong analytical, organizational, and problem-solving skills with attention to detail
- Excellent communication and leadership skills with the ability to influence across functions and levels
Benefits
- Unlimited PTO
- Lifestyle spending account
- Commuting reimbursement
- Competitive benefits package
Company overview
Rapport Therapeutics is a biotechnology company focused on developing precision medicines for central nervous system (CNS) disorders. The company specializes in targeting receptor-associated proteins (RAPs) to create novel therapeutics with improved efficacy and safety profiles for neurological and psychiatric conditions. By leveraging its proprietary platform technology, Rapport aims to identify and develop small molecule drugs that modulate specific protein-protein interactions within neural circuits, offering more targeted approaches to treating complex brain disorders. The company's research pipeline includes potential treatments for conditions such as epilepsy, neuropathic pain, and other CNS-related diseases where current therapeutic options remain limited. Rapport Therapeutics represents an innovative approach in the neuroscience field, combining molecular biology expertise with drug discovery capabilities to address unmet medical needs in neurology and psychiatry.