Data Analyst

Team Lead - CDM/PV

Qualification:

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:

• • 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.