Clinical Data Manager

Summary

iuvo Clinical is a full-service ophthalmology-focused contract research organization dedicated to advancing eye care therapies and supporting clinical trials. The Data Manager will build and maintain clinical trial databases, oversee data management activities, collaborate with project stakeholders and vendors, support data cleaning and database lock, and ensure compliance with applicable FDA and ICH/GCP guidelines.

Responsibilities

• Interface with clinical Project Manager(s) and statistician(s) to establish project data management plans and requirements, and database implementation schedules as well as other key study documents
• Participate in the department project clinical data system design, utilization, and maintenance to maintain conformance with FDA guidelines for clinical data management
• Collaborate with biostatisticians in the creation of analysis datasets
• Perform database quality assurance audits as needed
• Provide recommendations for improvement of project or divisional efficiencies based on work experience and observations
• Participate in project review meetings as requested
• Review protocols for CRF design and creation and develop electronic CRFs for use in clinical data management system
• Complete study specific database build activities in EDC system by creating database design specifications and edit checks for database programming and complete UAT
• May complete database programming activities in EDC system or work with programmer to set up as per database design specifications
• May train clinical site personnel and project team in the use of study-specific EDC and IWR system(s); conducts timely training and maintains training documentation
• Develop the Data Management Plan (DMP) and associated attachments, initiates DMP review and update per the specified review cycle
• Conduct timely study team training on the DMP and applicable attachments; maintains study training logs for project team(s)
• Maintain up-to-date study data documentation
• May support database build activities in CTMS as needed
• Work with external vendors on study for external data needs, setting up data transfer specifications and complete external data reconciliation as needed
• Complete coding or work with coding team on set up and coordination of coding activities
• Manually review data listings and manage ongoing query resolution. Analyze, and interpret data to identify trends, patterns, and insights
• Collaborate with teams to understand data requirements and provide data-driven recommendations
• Serve as main point of contact for data management activities on assigned project, and provide updates to study team and sponsor on project calls as needed
• Develop and provide data management metrics to project team as needed
• Complete data cleaning and other activities required for database lock
• Complete database lock activities as outlined in DMP
• Demonstrate knowledge of ICH/GCP guidelines as they relate to data management
• Demonstrate knowledge of FDA regulations related to data handling and processing
• Regularly provides or uploads data-related documents to the eTMF
• Ability to train junior data management team members

Skills

• Bachelor's Degree with a major/ focus in relevant discipline or equivalent - mathematics, statistics, computer science, life science or related discipline
• Minimum of three years' relevant work experience in data management
• Strong working knowledge of GCPs and Federal Regulations
• Current GCP certification required (or willing to obtain)
• Proficiency in data preparation, analysis tools and programming languages
• Proficiency in one or more EDC systems
• Proficiency with database design and systems, database technology and logical data analysis
• Experience working with CTMS and other clinical trial systems is preferred, as well as web-based software systems
• Understanding of SAS, Microsoft SQL
• Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable to position
• Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable
• Excellent presentation and interpersonal skills, including clear, succinct, and timely communication
• Read and comprehend work instructions/SOPs and protocols and write clear, concise communications and documentation
• Solid analytical and problem-solving skills; strong attention to detail and a commitment to data accuracy and integrity
• Strong organizational and business skills, with particular strength in follow-through
• Excellent interpersonal skills, including clear, succinct, and timely communication
• Ability to work independently with ability to build relationships and foster trust
• Leadership skills, and ability to work effectively within a team configuration
• Ability to work on multiple projects and manage competing priorities
• Familiarity with current data standards (e.g., XML/CDISC) and database administration
• While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk and hear
• Remote
• As required, estimated as <5%
• Experience working with CTMS and other clinical trial systems is preferred, as well as web-based software systems
• Previous database programming experience preferred but not required

Qualifications

Must Haves

• Bachelor's Degree with a major/ focus in relevant discipline or equivalent - mathematics, statistics, computer science, life science or related discipline
• Minimum of three years' relevant work experience in data management
• Strong working knowledge of GCPs and Federal Regulations
• Current GCP certification required (or willing to obtain)
• Proficiency in data preparation, analysis tools and programming languages
• Proficiency in one or more EDC systems
• Proficiency with database design and systems, database technology and logical data analysis
• Experience working with CTMS and other clinical trial systems is preferred, as well as web-based software systems
• Understanding of SAS, Microsoft SQL
• Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable to position
• Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable
• Excellent presentation and interpersonal skills, including clear, succinct, and timely communication
• Read and comprehend work instructions/SOPs and protocols and write clear, concise communications and documentation
• Solid analytical and problem-solving skills; strong attention to detail and a commitment to data accuracy and integrity
• Strong organizational and business skills, with particular strength in follow-through
• Excellent interpersonal skills, including clear, succinct, and timely communication
• Ability to work independently with ability to build relationships and foster trust
• Leadership skills, and ability to work effectively within a team configuration
• Ability to work on multiple projects and manage competing priorities
• Familiarity with current data standards (e.g., XML/CDISC) and database administration
• While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk and hear
• Remote
• As required, estimated as <5%

Nice to Haves

• Experience working with CTMS and other clinical trial systems is preferred, as well as web-based software systems
• Previous database programming experience preferred but not required

Benefits

• Remote work arrangement