Job Id
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18155
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Title
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Senior Clinical Data Analyst
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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Job Description
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MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
www.MakroCare.com
JOB RESPONSIBILITIES - Assume the ability to meet the requirements of a CDA with a high degree of proficiency and autonomy.
- Take responsibility for specific tasks on projects, or acts as the main point of contact for all the DM deliverables on individual projects.
- Train team members on selected tasks.
- Develop CRFs, Data Management Plan, eCRF filling instructions.
- Develop project specific guidelines, e.g. SAE handling, Medical Coding, Third Party data handling and Universal ruling guide lines documents.
- Develop Edit Checks document.
- Lead UAT activities of Screen Testing & Edit Checks testing.
- Lead Data validation and Query Management.
- Identifying and reporting protocol deviations and violations.
- Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.
- If required liaise with 3rd party vendors to clean electronic data.
- Perform Interim and final database QC activities.
- Update all relevant tracking system on an ongoing basis.
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Qualification
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Certification/Licensure
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Experience
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3-6 years
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Job Category
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Data Management
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Posted On
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1/28/2019
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Expires On
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3/28/2019
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