• Accountable for achieving project milestones from study start up through to delivery of database and monitoring of time spent of tasks

• Design the Case Record Form and guide process for CRF approval 

• Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team 

• For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF

• For EDC studies, timely response to issues identified by the eCRF Helpdesk  

• Prepare CRF completion guidelines  

• Prepare study specific data-entry guidelines and train data-entry staff  

• Perform term coding for clinical studies, raise manual queries for uncoded terms as required  

• Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual check and Medical Review listings  

• Apply SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities generating all the required documentation for study files  

• Prepare study specific data-entry guidelines and train data-entry staff  

• Input into and monitor progress against study project plan and escalate issues for resolution at the appropriate level  

• Run and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team  

• Perform timely data integration of CRF and non CRF data (data import from external sources)  

• Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc)  

• Define and execute QC plan, lead and execute database release and database freeze/lock activities  

• Plan and prioritise their own work and take appropriate actions

• Conducts other activities as required  

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