Our client is a global healthcare leader that manufactures a portfolio of life-changing medical technologies spanning the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
The Senior Clinical Data Management Analyst will lead and direct data management activities in support of R&D and clinical affairs. This role includes the development of data management processes, procedures, and best practices.
Maintain effective data management systems to ensure all analysis and reporting requirements for project groups are met. Provide support and resources to the Statistics, Clinical Affairs, and Science Support Groups where appropriate.
Role:
* Manage and support interrelated software, data entry, verification, analysis, and reporting activities.
* Ensure all clinical and in-house data entry/analysis is completed in a timely manner.
* Participate on clinical study teams and liaise with other departmental groups to establish priorities, communicate schedules, and ensure optimal resources are allocated to achieve desired outcomes.
* Support clinical studies including CRF design/review, database build and validation, creation of data management documents, and laptop setups.
* Manage and contribute to the monitoring of tasks and metrics to ensure quality and provide reports on the project/task status.
* Establish and support data systems.
* Advise on and develop systems for tracking data and study progress as necessary and supply feedback to study teams.
* Manage and contribute to the review of current practices and procedures, ensuring that all data management activities are completed to applicable regulatory policies and standards.
* Update and provide input into procedures, work instructions, and guidelines.
* Responsible for compliance with applicable Corporate and Divisional Policies and perform other duties as required.
Qualifications/Skills:
* Ideally a Scientific/Technical Degree or track record in a similar role.
* Clinical Data Management Analysis experience.
* Knowledge of relevant word processor applications, spreadsheets, and databases.
* Experience with EDC systems, either Rave, Oracle, or OpenClinica.
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