Ensure the quality and integrity of data collected in clinical studies and the privacy of patient data
Ensure efficient recording and reporting of safety-related issues
Conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock)
Create complex metrics to identify trends in data and remediation and utilize tools/reports to assess training needs
Define and specify clinically complex data collection requirements (eCRFs, CRFs, edit checks, collection of external data)
Define, perform, and coordinate user acceptance testing (test scripts and checklists)
Lead project management activities for multiple multi-site and multi-cohort projects, including team meetings, timelines, and stakeholder communications
Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids
Evaluate data errors and collection issues and provide guidance and recommendations for resolution
Perform Site/User Administration for database access and ensure users are qualified
Lead development and review of SOPs, work instructions, and associated CDM documents and participate in user training
Perform other incidental duties assigned by Leadership
Requirements
Bachelor's degree and 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry OR Associate degree or equivalent in a related field and 7 years of previous related experience in clinical research including clinical data management and/or clinical data entry
Experience with Medidata Rave EDC (Electronic Data Capture)
Minimum of 2 years leading clinical studies combined with 5 years of relevant experience in clinical research (preferred)
Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification (preferred)
Proven expertise in Microsoft Office Suite (preferred)
Advanced Excel skills (pivot tables and formulas) (preferred)
Microsoft Power BI (preferred)
Project management skills and ability to lead cross-functional meetings (preferred)
Full knowledge of processes and procedures in clinical data management (preferred)
Excellent written and verbal communication and interpersonal relationship skills, including negotiating and relationship management skills (preferred)
Excellent problem-solving and critical thinking skills (preferred)
Ability to work in a team environment and interact with senior internal and external personnel (preferred)
Must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days
Benefits
Competitive salaries
Performance-based incentives
Wide variety of benefits programs to address diverse individual needs of employees and their families
Staff Data Scientist building complex analytics models for underwriting and operations at Travelers Insurance. Collaborating with teams to enhance risk segmentation and streamline decision - making processes.
DSLDP Intern at Travelers developing data science solutions and collaborating with cross - function teams. Gain exposure through professional work experience and community outreach events.
Senior Product Analyst collaborating with teams to develop innovative products at Agência Estado. Key responsibilities include data analysis, market research, and facilitating product management processes.
Senior/Staff Data Scientist developing AI for commerce in the Middle East. Architecting systems for merchant and customer AI assistants and content generation.
Data Scientist leveraging statistical methods and machine learning techniques at FUCHS. Focus on data analysis, modeling, and collaboration for data - driven solutions.
Data Science Intern leveraging AI and ML technologies for product development at Seagate. Hands - on experience with data analysis, model development, and actionable insights generation.
Analyst within Credit Risk Management team identifying credit segmentation opportunities using statistical methods. Collaborating with teams to enhance credit decision process and policies.
Data Manager managing and analyzing company data at Amoddex, a consultancy for IT transformation projects. Ensuring data integrity and supporting strategic decision - making in a collaborative environment.
Data Scientist at Capital One on the LLM Customization Team utilizing the latest in computing and machine learning technologies. Collaborating with data scientists and engineers to deliver AI powered products.
Lead Full Stack Data Scientist at Tilt, building the intelligence layer for data - based decisions. Driving data science strategy and analytics to enhance product and growth insights.