Study Data Lead

Study Delivery

Provides support and training on the Clinical data management activities to TCS Data Managers for the relevant functional processes/work statements/projects - be trained and perform as back up where required

Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise

Overall in-charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close Out.

Primary point of contact for CDM and works are liaison for CP, DAS and CCS activities too

Monitors and evaluates overall study progress, identify the potential risk / challenges faced during the course of the study

Conducts regular team meetings for study updates and provides guidance on study related issues to internal teams

Monitor, maintain & report KPI / SLAs /metrics on the study

Ensures adequate resource for the Study throughout its lifecycle in collaboration with Group leader and informs (SDM and/or Alliance Manager (AM) as applicable) contact of any changes in staff

Keeps TCS Group Lead & Project Manager fully informed about the need for the resources so the resource requests can be finalized with AM and TCS PM

Keeps record of all activities to ensure the smooth flow of the study throughout its lifecycle

Set priorities and targets of the study within the CP, DM, CCS, DAS teams

Responsible for recruitment, selection, training of team members & managing attrition

Skills Required:

Excellent Technical skills, start-up knowledge is must

Excellent verbal and written skills, good organizational, interpersonal, and team skills

Project management & result orientation

Excellent Planning and Organizing skills

Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology