Clinical Data Manager
Waukegan, ILContractor
Behavioral Health Market Context
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Job Description
Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.
• Support data cleaning and validation activities to ensure completeness and accuracy of study data.
• Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.
• Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.
• Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.
• Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM) and collaborate with the study team to develop and implement risk mitigation strategies.
• Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).
• Supervise and provide guidance to junior CDM staff on assigned studies.
• Perform additional CDM-related duties as required.
Requirements:
• Bachelor's degree in a health-related, scientific, or equivalent field.
• 58 years of experience in Clinical Data Management role.
• Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.
• Hands-on experience with multiple Electronic Data Capture (EDC) systems.
• Familiarity with additional CDM tools and analytics platforms preferred.
• Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.
• Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.
• Excellent written and verbal communication skills.
• Strong organizational skills with keen attention to detail.
• Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.
• Support data cleaning and validation activities to ensure completeness and accuracy of study data.
• Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.
• Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.
• Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.
• Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM) and collaborate with the study team to develop and implement risk mitigation strategies.
• Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).
• Supervise and provide guidance to junior CDM staff on assigned studies.
• Perform additional CDM-related duties as required.
Requirements:
• Bachelor's degree in a health-related, scientific, or equivalent field.
• 58 years of experience in Clinical Data Management role.
• Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.
• Hands-on experience with multiple Electronic Data Capture (EDC) systems.
• Familiarity with additional CDM tools and analytics platforms preferred.
• Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.
• Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.
• Excellent written and verbal communication skills.
• Strong organizational skills with keen attention to detail.
• Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.
Qualifications
- •Bachelor's degree in a health-related, scientific, or equivalent field
- •58 years of experience in Clinical Data Management role
- •Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes
- •Hands-on experience with multiple Electronic Data Capture (EDC) systems
- •Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage
- •Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint
- •Excellent written and verbal communication skills
- •Strong organizational skills with keen attention to detail
- •Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively
Benefits
Responsibilities
- •Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines
- •Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities
- •Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy
- •Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications
- •Support data cleaning and validation activities to ensure completeness and accuracy of study data
- •Monitor study progress to ensure milestones are met and deliverables are achieved on schedule
- •Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines
- •Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines
- •Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM) and collaborate with the study team to develop and implement risk mitigation strategies
- •Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF)
- •Supervise and provide guidance to junior CDM staff on assigned studies
- •Perform additional CDM-related duties as required
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