Qualifications:

• Graduate/Post Graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse

Responsibilities:

Business/Customer:

• Minimal customer interaction under guidance
• Understand domain processes/sub-processes, functions, terminologies (e.g., SOP, QC checklists)
• Perform data entry of data received from source documents into the respective Clinical/Safety database, ensuring turnaround times and accuracy
• Handle more critical/sensitive transactions

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 as required

CDM (Clinical Data Management):

• Perform migrations/setup/closeout activities, as well as study conduct activities under supervision and quality checks from Team Lead
• Peer QC of the TJDA activities
• Generate all study-related reports and status updates, and handle all study-related email conversations and communications with internal stakeholders and clients

Project/Process:

• Handle complex problems and refer to Supervisor/Line Manager in rare cases
• Handle first-level processing of transactions
• Adhere to quality requirements, achieve targets/volumes within given turnaround time (TAT)
• Proactively identify issues and contribute to process improvement initiatives
• Identify and report process changes
• Adhere to 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 organizational hygiene and compliance needs in terms of personal utilization & timesheet submission, personal and new hire assimilation, attendance, and team initiatives
• Collate team performance metrics
• Manage break schedule/transport logistics for the team in the absence of the supervisor

Must-Have Skills:

• Pharma clinical process
• Clinical trial management
• Clinical data management

Application Link

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