Description

Qualifications: Graduate/Post Graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse Responsibilities: Business/Customer: Minimal Customer interaction under guidance. Understand Domain Process/sub-process, functions, terminologies (such as SOP, QC checklists). For PV/Complaints Management: Perform data entry of data received from source documents into the respective Clinical/Safety database. Responsible for meeting turnaround times and accuracy. Handle more critical/sensitive transactions. Coding: Perform coding activities on the assigned project with timelines and efficiency. Import uncoded terms into the database and export coded medical terms from the coding platform. Query Management. Create New Term Request and prioritize. Perform Dictionary upversioning activity as and when required. Clinical Data Management (CDM): Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks from the Team Lead. May perform Peer QC of TJDA activities. Generate all study-related reports, status updates, and carry out all study-related email communication with internal stakeholders and clients. Project/Process: Attempt complex problems (procedures/processes) and refer to Supervisor/Line Manager in rare cases. Handle first-level processing of transactions. Adhere to quality requirements, achieve targets/volumes in the given TAT (Turnaround Time). Proactively identify issues. Contribute to process improvement initiatives. Identify and report process changes. Adhere to mandatory industry regulations and compliance requirements for the given process. Knowledge Management: Update process documentation as appropriate under guidance. Participate in knowledge transfer. People/Team Management: Adhere to organizational hygiene and compliance needs, including: Personal utilization and time sheet submission. Personal and new hire assimilation. Attendance. 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

Role and Responsibilities

• Qualifications: Graduate/Post Graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse Responsibilities: Business/Customer: Minimal Customer interaction under guidance. Understand Domain Process/sub-process, functions, terminologies (such as SOP, QC checklists). For PV/Complaints Management: Perform data entry of data received from source documents into the respective Clinical/Safety database. Responsible for meeting turnaround times and accuracy. Handle more critical/sensitive transactions. Coding: Perform coding activities on the assigned project with timelines and efficiency. Import uncoded terms into the database and export coded medical terms from the coding platform. Query Management. Create New Term Request and prioritize. Perform Dictionary upversioning activity as and when required. Clinical Data Management (CDM): Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks from the Team Lead. May perform Peer QC of TJDA activities. Generate all study-related reports, status updates, and carry out all study-related email communication with internal stakeholders and clients. Project/Process: Attempt complex problems (procedures/processes) and refer to Supervisor/Line Manager in rare cases. Handle first-level processing of transactions. Adhere to quality requirements, achieve targets/volumes in the given TAT (Turnaround Time). Proactively identify issues. Contribute to process improvement initiatives. Identify and report process changes. Adhere to mandatory industry regulations and compliance requirements for the given process. Knowledge Management: Update process documentation as appropriate under guidance. Participate in knowledge transfer. People/Team Management: Adhere to organizational hygiene and compliance needs, including: Personal utilization and time sheet submission. Personal and new hire assimilation. Attendance. 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