Study Data Lead

Hirdetés feladója: Career Oppurtinities
Munkavégzés helye: Budapest XI. kerület (Pest megye)
Jelentkezési határidő: 2021. augusztus 25.
Várható kezdés: 2021. augusztus 26.

Elvárások a jelölttel szemben

  • 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


Szükséges nyelvismeretek

  • Nincs -


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 

Jelentkezés módja / egyéb közlendők