Team Lead – CDM/PVQualification:
Graduate/ Post Graduate/ Doctorate degree in life sciences/ Pharmacy/ Medical sciences/ Registered Nurse
- 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.
(same as SPE)
- 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.
- Limited to study conduct activities.
- Data review and Query management is done with assistance.
- Limited email conversations with Client.
- Every activity requires Peer QC by supervisor or allocated seniors.
- NO INVOLVEMENT in Set Up and Migration activities.
- Limited involvement of data pad locking activities during timelines of DataBase locks.
- Handles First level processing of assigned transactions, Complex problems (procedures/processes) are referred to Supervisor/Line Manager.
- Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time).
- Adhere to the mandatory industry regulation and compliance requirements for the given process.
- Knowledge Management:
- Understand various document templates and standards(Such as SOP’s) to interpret the documents & related terminologies.
- Adhere to org hygiene and compliance needs in terms of Time sheet submission, Assimilation & Attendance.
- MS Office