Clinical Data Management
- Golden Opportunities
- 2 - 9 Years
- Chennai
- 4 years ago
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Job Description
Clinical Data Management- Review and understand the study protocol and the timelines.
- Perform data review
- Implement study team feedback as required on the data.
- Perform external checks to handle manual discrepancies and action the same.
- Develop specifications
- Perform UAT for database
- Develop study specific procedures documents
- Ensure effective implementation of standard metric and status reporting on the study
- Ensure an error free
- Maintain data management study files and documentation
- Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor
- Identify out of scope tasks and bring to the attention of the TDM
- Assist the TDM in all study set up activities.
- Provide all study related reports to the TDM as per the request.
- Perform SAE reconciliation and Vendor data reconciliation
- Any other tasks deemed appropriate
- Good understanding of GCP and regulatory requirements related to data management systems and activities
- Experience of clinical databases
- Expertise in end-to-end core clinical data management activities
- Strong understanding of database structures
- Experience in supporting/building high impact innovation projects specifically in CDM space
Employement Category:
Employement Type: Full timeIndustry: PharmaceuticalFunctional Area: PharmaceuticalRole Category: ChemistRole/Responsibilies: Clinical Data ManagementContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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