We are currently looking to recruit an experienced Data Manager who also has knowledge of Pharmacovigilance activities.
The major tasks would be:
- Design, review and approve CRF design
- Database setup and testing
- Develop and maintain study-specific documentation (Data Management, Plan, Data Validation Plan, etc)
- Data Validation and query handling
- Generate data reports
- Develop training materials, work instructions, SOPs, and department procedures
- Handle safety data
- Perform expedited reporting of SUSARs
- Prepare periodic reports
Profile:
Knowledge of ICH-GCP
At least 8 years of experience as a Clinical Data Manager and 2 years experience in the Pharmacovigilance area.
Experience of working within a CRO environment, with solid understanding of the requirements of 21 CFR Part 11 and how this regulation affect clinical systems and data.
Knowledge of ICH Guidance for Industry E2B(M) + E2A.
Experience with Clinical Data Management Systems
Experience with Eudravigilance database.
Experience with Microsoft Office products.