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My client is currently seeking to recruit a Data Manager, Project Lead to work with them on a permanent basis. The role will be responsible for:
Provide project leadership for early phase clinical projects and programmes.
Coordinate the data management resources and activities for assigned studies to ensure that study deliverables are achieved on time and to the highest quality.
Ensure all projects are conducted in accordance with Good Clinical Practices (GCP), applicable SOPs, and client requirements.
For each project, maintain all required Data Management documentation
Direct, lead, or perform the development and quality reviews of key study documents
Direct, lead, or perform the development, validation, and User Acceptance Testing of the clinical data management system database and associated edit checks.
Direct, lead, or perform all Data Management data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database close/lock, and relevant archiving of study materials.
Provide project team training in Data Management systems and processes.
Represent the Data Management and SAS Programming department for internal and external meetings, presentations, and audits.
May serve as a mentor for other staff in the Data Management group, and provide input to the performance appraisal process as requested.
May provide leadership or participation on special projects, as required.
May participate in Business Development activities, including proposal development, providing input to costing, and attending bid defense meetings, as required.
Experience and Qualification
Bachelor's degree or local equivalent in a relevant discipline.
Prior relevant data management experience.
Prior experience leading clinical data management project is required.
Knowledge of applicable regulatory requirements as they relate to clinical data management practices.
Ability to liaise successfully with project teams and sponsors, including excellent written and verbal communication skills.