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Job Id 18155
Title Senior Clinical Data Analyst
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description 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.

Qualification
Experience 3-6 years
Job Category Data Management
Posted On 1/28/2019
Expires On 3/28/2019
 
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