Clinical Data Manager

Katalyst CRO; Jacksonville (FL); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an experienced Lead Clinical Data Manager in Jacksonville, FL to drive data management across complex studies from startup through database lock. You will design and manage EDC databases, maintain study documentation, and ensure data quality with robust validation and cleaning processes.

You will collaborate with clinical operations, biostatistics, and regulatory teams, oversee vendor relations, and advance data management systems and tools to improve trial efficiency.

Qualifications

• Bachelor's or master's 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.
• Proficiency with EDC systems (Medidata Rave, Medrio).
• Strong understanding of CDISC standards (CDASH, SDTM, ADaM) and coding.
• Familiarity with data reporting tools is a plus.
• Thorough understanding of regulatory requirements (FDA, EMA) and GCP.
• Strong leadership and ability to manage multiple priorities.

Responsibilities

• Lead clinical data management activities for multiple complex studies from startup to final reporting.
• Develop and manage data management timelines for multiple projects.
• Design and oversee databases using EDC systems (Medidata, Medrio or similar).
• Maintain data management documentation across studies.
• Ensure accurate data capture with validation checks and edit checks.
• Oversee data validation, cleaning, discrepancy management and queries.
• Ensure compliance with regulatory requirements and industry standards.
• Prepare regulatory submissions and support data auditing processes.
• Collaborate with clinical operations, biostatistics, medical writing, and regulatory teams.
• Serve as primary contact for data management vendors and external partners.
• Manage CRO biostatistical services and budgetary efficiency.
• Develop and improve clinical data management processes and systems.
• Lead initiatives to enhance efficiency and evaluate new tools and methodologies.

Skills

EDC systems

CDISC standards

GCP compliance

Project management

Vendor management

FDA/EMA regulations

Leadership

Data quality

Education

Bachelor's degree in life sciences

Master's degree in health informatics or life sciences

Tools

Medidata Rave

Medrio

Job description

• 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.

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.

Requirements

• Bachelor's or master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred.
• 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.
• Familiarity with data reporting tools is a plus.
• 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.
• Certified Clinical Data Manager (CCDM) or similar certification is preferred.