Cognizant PROCESS SPECIALIST – VOICE Graduate/Post Graduate/
Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse
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.
• These associates are usually used to handle more
critical/senitive transactions.
• These associates also act as Subject Matter Expert.
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.
• • Send Coding (Consistency) Reports.
• • Participate in study related meetings as needed.
• • Provide feedback on quality related issues to other
medical coders in timely manner.
• • Serve as an SME to Medical Reviewers regarding coding
activities & guidelines.
• • Perform UAT for coding related applications.
• • Perform Operational QC.
• • Mentor Team Member.
• • Coordinate with CDM working on the same study.
• • Coordinate to resolve Rave specific issues.
CDM:
• 1 Execute Data Management Activities ie Data Cleaning,
Executing Manual and System checks, Update relevant trackers, Discrepancy and
query management, Issue resolution, Database lock activities.
• 2 Participate in innovation and process improvement
initiatives.
• 3 Identify and develop action plan in coordination with the
TL for activities not meeting the client SLAs.
• 4 Archive all necessary information for audit purposes
according to quality and security requirements, to ensure reliable and timely
retrieval of documentation and information.
• 5 Support multiple clinical trials, across diverse
therapeutic areas, to successful conclusion and provide technical oversight
when required.
Project / Process:
• Attempts Complex problems (procedures/processes) and refers
to Supervisor/Line Manager in rare cases.
• Handle first level processing of transactions.
• Adhere to quality requirements, achieve targets/volumes in
given TAT(Turn around time).
• Proactively identify issues.
• Contribute to process improvement initiatives.
• Identify and report process changes.
• Adhere to the mandatory industry regulation and compliance
requirements for the given process.
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