Lead Clinical Data Manager

EPM Scientific; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

EPM Scientific seeks an experienced Lead Clinical Data Management professional to oversee CDM tasks for studies, including CRF design, DMP development, and data validation.

You will liaise with vendors/CROs, ensure SOP/GCP compliance, manage timelines and budgets, and mentor junior staff while driving data quality.

Qualifications

• Experience leading clinical data management activities.
• Ability to manage external vendors/CROs.
• Familiarity with SOPs and GCP.
• Experience in CRF design and DMP development.

Responsibilities

• Lead all Clinical Data Management tasks for a project, including CRF development and DMP.
• Oversee CDMS implementation and data processing plans.
• Ensure data within timelines and budget specifications.
• Lead study start-up through database lock in collaboration with teams.
• Monitor data flow for timely, high-quality data for analysis.
• Ensure compliance with SOPs, GCP and regulatory requirements.
• Manage budgets, assess change orders and control costs.
• Mentor junior team members and drive best practices.

Skills

Leadership

Cross-functional collaboration

Vendor management

Data management

Education

Bachelor's degree in related scientific discipline

Job description

• Lead all Clinical Data Management tasks for a project including the development of eCRFs, eCRF completion guidelines, Data Management Plan (DMP) and other Clinical Data Management documents in collaboration with applicable service providers and/or internal teams.
• Oversee the implementation of project specific Clinical Data Management Systems and/or processes for assigned projects
• Oversee the implementation of plans for the processing of data within established timelines and budget specifications, and make necessary adjustments based upon project needs.
• Lead clinical data management activities from study start-up through database lock in collaboration with applicable service providers and/or internal teams.
• Design, review, and finalize case report forms (CRFs) in collaboration with cross functional team members.
• Develop and maintain data management plans, data review guidelines, and edit check specifications.
• Oversee database development, validation, user acceptance testing and go live activities
• Monitor data flow, ensure timely and quality data availability for analysis
• Ensure compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives.
• Manage and collaborate with external vendors, CROs, and partners related to outsourced data management tasks to ensure timely and quality data deliverables.
• Represent data management in cross-functional meetings and communicate project status, risks, and resolutions.
• Provide analysis and feedback (questions, issues and possible resolutions) to the line manager and/or project team on Clinical Data Management tasks, systems or processes.
• Contribute to the development and improvement of data management processes and tools.
• Monitor and manage study budgets to ensure financial efficiency and compliance. Assess change orders, evaluating cost overruns to mitigate financial risk while maintaining study integrity.
• Train and mentor junior team members, promoting best practices in clinical data standards and compliance.
• Participate in audits and inspections, contributing to the development of corrective and preventive actions.
• Communicate with all departments as necessary regarding project status/issues.
• Perform other duties as assigned
  

• Lead all Clinical Data Management tasks for a project including the development of eCRFs, eCRF completion guidelines, Data Management Plan (DMP) and other Clinical Data Management documents in collaboration with applicable service providers and/or internal teams.
• Oversee the implementation of project specific Clinical Data Management Systems and/or processes for assigned projects
• Oversee the implementation of plans for the processing of data within established timelines and budget specifications, and make necessary adjustments based upon project needs.
• Lead clinical data management activities from study start-up through database lock in collaboration with applicable service providers and/or internal teams.
• Design, review, and finalize case report forms (CRFs) in collaboration with cross functional team members.
• Develop and maintain data management plans, data review guidelines, and edit check specifications.
• Oversee database development, validation, user acceptance testing and go live activities
• Monitor data flow, ensure timely and quality data availability for analysis
• Ensure compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives.
• Manage and collaborate with external vendors, CROs, and partners related to outsourced data management tasks to ensure timely and quality data deliverables.
• Represent data management in cross-functional meetings and communicate project status, risks, and resolutions.
• Provide analysis and feedback (questions, issues and possible resolutions) to the line manager and/or project team on Clinical Data Management tasks, systems or processes.
• Contribute to the development and improvement of data management processes and tools.
• Monitor and manage study budgets to ensure financial efficiency and compliance. Assess change orders, evaluating cost overruns to mitigate financial risk while maintaining study integrity.
• Train and mentor junior team members, promoting best practices in clinical data standards and compliance.
• Participate in audits and inspections, contributing to the development of corrective and preventive actions.
• Communicate with all departments as necessary regarding project status/issues.
• Perform other duties as assigned
  

Desired Skills and Experience

• Bachelor's degree in related scientific discipline