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Responsibilities:
Business/Customer:
- Minimal customer interaction under guidance.
- Understands domain processes, sub-processes, functions, and terminologies (e.g., SOP, QC checklists).
- For PV/Complaints Management: Perform data entry of information received from source documents into the Clinical/Safety database, ensuring turnaround times and accuracy.
Coding:
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- Perform coding activities on assigned projects within timelines and efficiency.
- Import uncoded terms into the database and export coded medical terms from the coding platform.
- Manage queries and create “New Term Request” with prioritization.
- Perform dictionary upversioning activities as required.
CDM:
- Limited to study conduct activities.
- Assist with data review and query management.
- Limited email conversations with clients.
- Every activity requires Peer QC by a supervisor or allocated senior.
- No involvement in Set Up and Migration activities.
- Limited involvement in data padlocking activities during database lock timelines.
Project/Process:
- Handles first-level processing of assigned transactions. Complex problems are referred to Supervisor/Line Manager.
- Adhere to quality requirements and achieve targets/volumes within the given TAT (Turnaround Time).
- Adhere to mandatory industry regulations and compliance requirements for the given process.
Knowledge Management:
- Understand various document templates and standards (such as SOPs) to interpret documents and related terminologies.
People/Team Management:
- Adhere to organizational hygiene and compliance needs regarding time sheet submission, assimilation, and attendance.
Must-Have Skills:
- Excel Services on SharePoint
- Complaint Management – Life Sciences
- Customer & Service Excellence
- Pharmacovigilance & Safety Operations
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