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.

CODING:

(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.

• • Query Management.

• • Create “New Term Request” and prioritize.

• • Perform Dictionary upversioning activity as and when required.

CDM:

• 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.

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

• Pharma clinical process

• Clinical Site Management

• Clinical Data Management