Samir

Designation & Department: Senior Technical Associate - Clinical Data Management

(Jan-2019 to till present)

Lambda Therapeutic Research Ltd.

Lambda House | Plot No.38 | S.G. Highway | Gota | Ahmedabad - 382 481 | Gujarat | INDIA

• JOB RESPONSIBILITIES: -
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• Mentoring and coaching new joiner(s) and team members on CDM process and SOPs as per assignment, if assigned
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• Follow the Data Management Plan requirement throughout the project
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• Preparation and review of documents generated during life of the project. E.g. Case Report Form (CRF), CRF Completion guideline, Data Validation Plan (DVP), edit check document, project specific self-evident correction etc.
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• Database designing and testing
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• Edit checks implementation, testing and documentation
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• Data Validation includes DCF generation and resolution, manual review of clinical data to check the discrepancy (ies)
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• Correction of clinical data as per investigator’s suggestion or Self-Evident Correction
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• Preparation and review of other document(s) related to CDM process and project(s)
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• Check study specific CDM binder for completeness and correctness of required documents
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• Maintenance of study binder in eTMF
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• Coordination within and across the department for project related activity(ies)
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• Co-ordination with sponsor for any project related activities along with clinical data manager/ HOD
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• Work as a Clinical Data Coordinator for assigned projects
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• Archiving of study specific documents and document controls
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• Follow the CDM SOPs, other departmental SOPs and applicable regulatory guidelines
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• Medication coding by WHODD