Job Description
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.
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:
• 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.
• 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.
• 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.
• 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.
• 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.
• Adhere to org hygiene and compliance needs in terms of Time sheet submission, Assimilation & Attendance.
Candidate Profile
Graduate / Post Graduate / Doctorate degree in life sciences / Pharmacy / Medical sciences / Registered Nurse
Graduate / Post Graduate / Doctorate degree in life sciences / Pharmacy / Medical sciences / Registered Nurse
Additional Information
Qualification : M.Pharm, B.Pharm, Ph.D
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th April, 2019
Qualification : M.Pharm, B.Pharm, Ph.D
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th April, 2019
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