Process Specialist

2 months ago


Hyderabad, India Cognizant Technology Solutions Full time

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.

Knowledge Management:

  • Update Process documentation as appropriate for the process under guidance.
  • Participate in knowledge transfer.

People/Team Management:

  • Adhere to org hygiene and compliance needs in terms of.
  • a Personal Utilization & Time sheet submission.
  • b Personal and new hire Assimilation.
  • c Attendance.
  • d Team Initiatives.
  • Collate team performance metrics.
  • Manage break schedule/transport logistics for the team in the absence of his/her supervisor.

Must Have Skills

  • Customer Service-LS

Good To Have Skills

  • Connected Health

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