Clinical Data Manager
|Job Title:||Clinical Data Manager|
|Salary:||£25 - £30 per hour|
|Contact Name:||Elizabeth Smith|
|Job Published:||June 13, 2017 09:24|
An opportunity has arisen for a Clinical Data Manager to join a global pharmaceutical company based in Hertfordshire for an initial 6 month contract.
The Clinical Data Manager will be responsible for the study setup, conduct and close down for clinical studies. Review of study related documents i.e. CRF, Electronic Case Report Form.
Outline of role and responsibilities:
- Study setup, conduct and close down for one or more clinical studies.
- Review of study related documents i.e. Protocol, (CRF) Case Report Form, Electronic Case Report Form (eCRF), etc.
- Maintain and oversee the eCRF design and performs UAT required.
- Work closely with programmers and/or statisticians to ensure correct study design and data extract mapping.
- Define edit checks and behaviors for in-sourced studies and maintain an oversight on outsourced studies.
- Create and maintain study related documentation i.e. Data Management Plan (DMP), study Completion Guidelines, etc.
- Provide support and training to site staff on aspects of the study including data capture tools, i.e. eCRF entry and related documentation.
- Ensure in house eCRF user accounts are created and maintained.
- Lead and coordinate data management activities to ensure delivery of a high quality database to enable data extraction and analysis.
- Perform and maintain discrepancy management, data cleaning, sample reconciliation and any other tasks related to the study.
- Review of protocol amendments, perform impact and risk assessment and ensure any updates are agreed and performed within agreed timelines.
- Perform and ensure all study related documentation is appropriately updated, filed and archived at study end.
- Provide Metrics and reports to show the status of the study.
- Ensure coding and SAE reconciliation is performed.
- Create and maintain relevant SOP's.
- Provide support and training to internal staff and line manage as required.
To be considered for this role, you must have experience of Merge eClinical OS and an EDC background.
If interested, please apply immediatly.
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