Team Lead – CDM/PV
Qualification:Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse
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.
CODING:(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.
CDM:
- 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.
Project / Process:
- 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.
People/Team Management:
- Adhere to org hygiene and compliance needs in terms of Time sheet submission, Assimilation & Attendance.
Must Have Skills
- Generative AI
- PV Case Processing
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