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.
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