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Job Location: Pune
Job Detail:
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.
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
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