Samir

Senior Technical Associate
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Location  Ahmedabad
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Member since 30+ Days ago
 
Candidate Information
  • User Experience
    Experience  8 Year
  • Cost
    Hourly Rate $4
  • availability
    Availability Immediate
  • work from
    Work From Any
  • check list
    Category Health Wellness & Fitness
  • back in time
    Last Active On January 13, 2022
Key Skills
Clinical Data Management Medical Coding
Summary

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: -

  • Mentoring and coaching new joiner(s) and team members on CDM process and SOPs as per assignment, if assigned

  • Follow the Data Management Plan requirement throughout the project

  • 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.

  • Database designing and testing

  • Edit checks implementation, testing and documentation

  • Data Validation includes DCF generation and resolution, manual review of clinical data to check the discrepancy (ies)

  • Correction of clinical data as per investigator’s suggestion or Self-Evident Correction

  • Preparation and review of other document(s) related to CDM process and project(s)

  • Check study specific CDM binder for completeness and correctness of required documents

  • Maintenance of study binder in eTMF

  • Coordination within and across the department for project related activity(ies)

  • Co-ordination with sponsor for any project related activities along with clinical data manager/ HOD

  • Work as a Clinical Data Coordinator for assigned projects

  • Archiving of study specific documents and document controls

  • Follow the CDM SOPs, other departmental SOPs and applicable regulatory guidelines

  • Medication coding by WHODD