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Study Data Lead

2020.12.09. | Budapest | Non-tech
Tasks

- 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
- Single point of contact for clientStudy Data Manager / designee
- 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 client as well TCS internal teams
- Monitor, maintain & report KPI / SLAs /metrics on the study
- Performs tasks/activities as communicated by the TCS Group Leader (GL) and / or Project Manager (PM) and clientStudy Data Manager (SDM)
- Ensures adequate resource for the Study throughout its lifecycle in collaboration with Group leader and informs client (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 clientAM 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
- Works as mentor for DM staff assigned on the study/ies

Expectations

- 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
- Experience in Clinical Data Management is required
- Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Knowledge of PL/SQL is not required, but will serve as a recommendation
- Ability to work across scientific and technical disciplines