Study Data Lead

Feladatok és tevékenységek
Primary Responsibilities

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 a backup where required
Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise
Single point of contact for client study Data Manager/designee
Overall in charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close Out.
The primary point of contact for CDM and works are the 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 guides study-related issues to the 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 client study 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 the client 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 a mentor for DM staff assigned on the study/ies


Követelmények
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MS Office |Középszintű

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

Amit kínálunk
A career path that will allow you to become a Subject Matter ExperGet trained on various competencies and skills
A great diversity of cultures
Language courses and training
On-site relax & gym rooms
Volunteering, sport and employee events

FONTOS!!!!
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https://talentuno.com/jobs/study-data-lead-0001#RCE0820

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Köszönöm
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