Clinical Data Management @ Golden Opportunities

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Clinical Data Management

Golden Opportunities
2 - 10 Years
Chennai
5 years ago
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Job Description

Job Description:
CDM Data Manager

Review and understand the study protocol and the timelines.
Perform data review data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate.
Implement study team feedback as required on the data.
Perform external checks to handle manual discrepancies and action the same.
Develop specifications implementation and testing for the edit checks and listings (DVS)
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 quality data with no open queries.
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 different clinical data management systems and electronic data capture (EDC)
Expertise in end-to-end core clinical data management activities
Strong understanding of database structures data standards (CDISC) and practices
Experience in supporting/building high impact innovation projects specifically in CDM space

Location : Pan India

Employement Category:

Employement Type: Full time
Industry: Bio Technology & Life Sciences
Functional Area: Pharmaceutical
Role Category: Data Management
Role/Responsibilies: Clinical Data Management

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

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Clinical Data Management @ Golden Opportunities

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