Company: Docs Global (Continental Europe)
Location: Leiden area,Netherlands
Reference: Ref AS-019084
Closing Date: 23 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
You will provide management, technical consulting and support for the design, implementation and maintenance of study databases/data repository. You will ensure application integrity and recoverability of the databases and develops specific data management standard procedures.
Roles & Responsibilities of the position
- Keeps senior technical management informed by preparing reports on system performance and problems.
- Maintains good professional relationship with external vendors/CROs, peers, staff and management.
- The DM oversees maintenance of database/data repository and ensures accuracy, integrity and completeness of data.
- Analyzes existing processes and streamline to maximize process efficiency.
- In collaboration with the project team, determines clinical and lab data needed to be collected and the appropriate data resources needed, reviews and comments on data collection systems and study specific collection setup.
- Provides input to the study team/vendors to improve data integrity and data quality to ensure decision making on good quality data.
- Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
- Develops, reviews and manages Data Transfer Agreement(s) (DTAs) between external data vendors and/or core and plans/organizes secure data transfers in line with project requirements and timelines.
- Demonstrated data management expertise within the field of clinical trials according to applicable standards, guidelines and procedures.
- Able to define SOPs and processes for the DM function and activities.
- Minimum of 8 years of experience in the data management related to clinical studies.
- Complete understanding and application of clinical research procedures.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related data requirements and terminology.
- Working knowledge of Clinical database applications and DM SOPs.
- Applicable knowledge working with clinical databases, EDC systems, back-end database tools, SAS or other packages.
- Strong communication, organizational and interpersonal skills.
- Flexibility and ability to adapt and adjust to changing priorities.
- Good leadership skills.
For more information, please contact:
2 Globeside, Globeside Business Park
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