Senior Specialist Study Execution Team Evidence Solution Group
Senior Specialist Study Execution Team Evidence Solution Group
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Job Description
Mission Statement:
The Senior Specialist of Study Execution Team Evidence Solution Group Medical is responsible for ontime study execution upon regulatory Post Marketing Observational Studies and nonregulatory noninterventional studies. The Senior Specialist works as a study manager the role contains study planning study management and study quality management.
Major Responsibilities:
- Work as a study manager according to the GPSP/GCP and SOP
- Codevelopment of Risk Management Plan with Pharmacovigilance Group and corresponding to PMDA
- Study Protocol translation and study related material development
- Study planning (incl. feasibility study budget risk etc.) execution and management
- Education of the study for Study Monitoring organization (MR/CRO)
- Essential Document archiving
Qualifications :
Essential Skills & Abilities:
- Knowledge of GCP GPSP or Ethical Guidelines for Medical and Health Research Involving Human Subjects
- Business level English (TOEIC 700 or above)
- Good communication skill
Education/Experience Required:
- Bachelors degree in science who has experience as CRA or MSL (or MR; only in Abbvie)
- Bachelors degree in science who has experience as clinical research
- Master or PhD in science who has experience with scientific research in industry or academia
- PhD in epidemiology
- Healthcare related certified person preferred (eg MD pharmacist etc.)
:
AbbVieAbbVie
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
