Study delivery specialist

Role: Study delivery specialist

Job Location Mumbai, Pune
Experience Range 4 to 9 Years
Domain: Life Sciences  
Educational Qualification(s) Required Graduate/Postgraduate (Any life-science/ Engineering)

Responsibilities:  
1.Organize study start-up teleconferences with study team, if required.  
2.Assist in study start-up activities and ensure compliance for the Drug Shipment as per Client SOP’s.  
3.Update and maintain the data with accuracy and integrity within all relevant Client study systems.  
4.Supporting Client Clinical Study team to meet urgent deliverables ensuring inspection readiness.  
5.Assist the study teams in the close out activities to ensure compliance to SOP and effective study 
closure. 
6.Compilation and generation of Clinical Study Report Modular Appendices.  
7.Manage and Archive essential documents as per Client Sponsor TMF SOP.  
8.Ensure the process KPI defined are met for the study.  
9Organize and participating in all appropriate meetings with Client and TCS.  

Skills requirement:  
• Graduates/ Postgraduate in Life Science/ Pharma        
• Excellent interpersonal and communication skills (verbal and communication)  
• Good knowledge of Clinical Research Industry and ICH-GCP  
• Computer Literacy (Strong working knowledge of Ms Excel and PowerPoint)  
• Clinical experience – minimum 2-3 yrs (CRA- Monitor/ CRC / Centralized monitoring)  
• Effective work management skills