Business/Customer:
- Minimal customer interaction under guidance.
- Understands domain processes, sub-processes, functions, and terminologies (such as SOP, QC checklists).
- Performs data entry of information received from source documents into the respective Clinical/Safety database. Ensures accuracy and turnaround times are met.
- Handles more critical/sensitive transactions.
Coding:
- Perform coding activities on the assigned project within timelines and efficiency.
- Import uncoded terms in the database and export coded medical terms from the coding platform.
- Manage queries and create “New Term Requests” and prioritize them.
- Perform dictionary upversioning activities as required.
Clinical Data Management (CDM):
- Perform migrations, setup, and closeout activities in addition to study conduct activities under supervision and quality checks from the Team Lead.
- Conduct peer quality control (QC) of TJDA activities.
- Generate all study-related reports and status updates.
- Manage study-related email conversations and communications with internal stakeholders and clients.
Project/Process:
- Attempt to solve complex problems (procedures/processes) and refer to Supervisor/Line Manager in rare cases.
- Handle first-level processing of transactions.
- Adhere to quality requirements and achieve targets/volumes within the given turnaround time (TAT).
- Proactively identify issues and contribute to process improvement initiatives.
- Identify and report process changes.
- Adhere to mandatory industry regulations and compliance requirements for the given process.
Knowledge Management:
- Update process documentation as appropriate under guidance.
- Participate in knowledge transfer activities.
People/Team Management:
- Adhere to organizational hygiene and compliance needs in terms of personal utilization, time sheet submission, new hire assimilation, attendance, and team initiatives.
- Collate team performance metrics.
- Manage break schedules and transport logistics for the team in the absence of the supervisor.
Must-Have Skills:
- Pharma clinical process
- Clinical site management
- Clinical data management
