Team Lead - CDM/PV
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.
(same as PE)
Perform coding activities on the assigned project with timelines and efficiency.
Import uncoded terms in database and export coded medical terms from coding platform.
Create New Term Request and prioritize.
Perform Dictionary upversioning activity as and when required.
Performs Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks from Team Lead.
May do the Peer QC of the TJDA activities.
Generates all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.
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.
Update Process documentation as appropriate for the process under guidance.
Participate in knowledge transfer.
Adhere to org hygiene and compliance needs in terms of.
a Personal Utilization & Time sheet submission.
b Personal and new hire Assimilation.
d Team Initiatives.
Collate team performance metrics.
Manage break schedule/transport logistics for the team in the absence of his/her supervisor.