Project Coordinator II

Job Location(s) IN-Bangalore
Job Number
Job Category
Clinical Data Management
Position Type

Job Overview

- Understand the Project specific documents (e.g. DMP) with regards to Scanning, Indexing, Data Entry, tracking and administrative tasks and follow the guidelines contained within it
- Perform Scanning and Indexing of study related documents like CRFs, DCFs, sDCFs and other related documents/pages as specified in the project DMP
- Database set up: conduct user acceptance testing for data entry screens
- Demonstrate/describe the relevant processes to sponsors/auditors
- Set up and maintenance of user account requests for databases
- Assist teams with meeting minutes, preparing agendas, posting of documentation, running and distributing reports and other ad hoc tasks
- Create instructions for preparing metric and sponsor reports, and provide training to staff
- Assist Data Management staff with administrative duties including the organizing, sending, decommissioning tasks, receiving, and tracking of correspondence for assigned projects
- Ability and eye-for-detail to handle multiple tasks
- Takes ownership for maintaining project files, eTMF/TMFs in accordance with relevant regulatory requirements
- Works with Data Management to create and maintain Trial Master File Plan and Index.
- Generate and maintain the eTMF tracker, working with Study Project Manager, study teams and applicable business partners for reconciliation of the files as part of the quality control process.
- Pro-actively maintains documents within the standardized filing structure for study documents.
- Gathering, organising, scanning and shipping of project documentation as required.
- Perform archiving duties on all paper and electronic media storage
- Performing documentation quality checks, identifying and following up on quality issues with relevant DM staff.
- Assist department management team with maintaining tracking tools and metric data
- Training and supporting others in study filing, archiving, decommissioning and eTMF practices
- Works in a timely manner in accordance with all the activities specified in the DMP (Data Entry, QC) under supervision and guidance of the Lead Data Manager
- Performs any other duties as assigned


BSc. degree in Life Science/Pharmacy or equivalent/related discipline is preferred


1 or 2 years relevant industry experience


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