Skills : Java,IT Proficiency
Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists).
Responsibility:
Business/ Customer:
• Minimal Customer interaction under guidance.
• Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists).
• For PV/Complaints Management Individuals in this role perform data entry of data received from Source documents into the respective Clinical/Safety database While peroforming this activity the associate is responsible for meeting turnaround times and accuracy.
• These associates are usually used to handle more critical/senitive transactions.
CODING: (same as PE)
• Perform coding activities on the assigned project with timelines and efficiency.
• Import uncoded terms in database and export coded medical terms from coding platform.
• Query Management.
• Create “New Term Request” and prioritize.
• Perform Dictionary upversioning activity as and when required.
CDM:
• Performs Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks from Team Lead.
• May do the Peer QC of the TJDA activities.
• Generates all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client. Project / Process:
• Attempts Complex problems (procedures/processes) and refers to Supervisor/Line Manager in rare cases.
• Handle first level processing of transactions.
• Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time).
• Proactively identify issues.
• Contribute to process improvement initiatives.
• Identify and report process changes.
• Adhere to the mandatory industry regulation and compliance requirements for the given process. Knowledge Management:
• Update Process documentation as appropriate for the process under guidance.
• Participate in knowledge transfer.