Ecocareers ยท 4 days ago
Clinical Data Manager
Jacksonville, FL
Full-time
Onsite
Senior Level
5+ years expEcocareers is a company focused on clinical data management, and they are seeking a Clinical Data Manager to lead data management activities for complex studies. The role involves overseeing the design and implementation of clinical trial databases, ensuring data accuracy and compliance, and collaborating with various teams to enhance clinical trial processes.
Staffing & Recruiting
Responsibilities
Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting
Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans
Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar)
Develop and oversee maintenance all data management documentation for all clinical studies
Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks
Oversee data validation processes, including data cleaning, discrepancy management, and query resolution
Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA)
Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process
Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations
Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution
Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution
Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
Develop, implement, and continuously improve clinical data management processes and systems
Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies
Qualification
Required
Bachelor's or master's degree in life sciences, health informatics, computer science, or related field
Strong understanding of data structure and data systems
Minimum of 5+ years of experience in clinical data management
Proven experience managing data across multiple phases of clinical trials
Proficiency with EDC systems (e.g., Medidata Rave, Medrio)
Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding
Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP standards
Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment
Excellent communication, problem-solving, and decision-making skills
Ability to work collaboratively with cross-functional teams and manage relationships with external vendors
Preferred
Advanced degree preferred
Familiarity with data reporting tools is a plus
Certified Clinical Data Manager (CCDM) or similar certification is preferred
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase