Lead-Clinical data Management

Tech Observer; Manchester; On-site; GBP 55,000 - 75,000; Full time

Job summary

Tech Observer in Manchester is seeking a seasoned Clinical Data Management professional to lead end-to-end CDM activities from database setup to database lock, ensuring top-tier data quality and regulatory compliance across sponsor projects.

You will coordinate with Clinical Operations, SAS/Statistics, Medical Writing, and external vendors; develop SOPs, train staff, manage timelines, review documentation, and escalate issues to senior management to ensure timely, audit-ready data delivery.

Responsibilities

• Responsible for end to end Clinical Data Management services stating from Clinical Database Set Up to Database Lock.
• Representing Data Management services to Local and / Global Sponsors
• Providing CAPA to Internal Audits, External Audits and Regulatory Inspections
• To ensure expedited resolutions on critical/significant changes/query required in projects as per feedback from sponsor
• Developing and revising SOPs, WIs (Working Instructions), Presentations on all CDM process.
• Training team on data management processes in compliance with current guidelines , Regulations and Industry Practices.
• Communication with sponsor on all project management related activities like DM Project start up, Planning timeline, deliverables for projects, Project progress and Project closure
• Communication with all cross functional teams – Clinical Operation team, SAS & Bio-statistics team, Medical writing team, Central Lab including external vendors as required in a project
• Protocol review as per Data Management prospective
• Provide leadership and motivation to DM team, setting team KRAs, completing task allocation, and determine resource needs
• Review and approval of timesheet of all DM staff.
• Reviewing and approving all CDM projects documentation and process
• Escalation of significant issues to Senior Management for DM Projects
• Any Other responsibilities as assigned by Reporting Head and / Senior Management
• Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
• leads process development, audits, training, and project management activities, while providing leadership and guidance to the team, ensuring timely and high-quality delivery of data

Job description

• Responsible for end to end Clinical Data Management services stating from Clinical Database Set Up to Database Lock.
• Representing Data Management services to Local and / Global Sponsors
• Providing CAPA to Internal Audits, External Audits and Regulatory Inspections
• To ensure expedited resolutions on critical/significant changes/query required in projects as per feedback from sponsor
• Developing and revising SOPs, WIs (Working Instructions), Presentations on all CDM process.
• Training team on data management processes in compliance with current guidelines , Regulations and Industry Practices.
• Communication with sponsor on all project management related activities like DM Project start up, Planning timeline, deliverables for projects, Project progress and Project closure
• Communication with all cross functional teams – Clinical Operation team, SAS & Bio-statistics team, Medical writing team, Central Lab including external vendors as required in a project
• Protocol review as per Data Management prospective
• Provide leadership and motivation to DM team, setting team KRAs, completing task allocation, and determine resource needs
• Review and approval of timesheet of all DM staff.
• Reviewing and approving all CDM projects documentation and process
• Escalation of significant issues to Senior Management for DM Projects
• Any Other responsibilities as assigned by Reporting Head and / Senior Management
• Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
• leads process development, audits, training, and project management activities, while providing leadership and guidance to the team, ensuring timely and high-quality delivery of data