![Grand Pacific CRO](https://media.trabajo.org/img/noimg.jpg)
Clinical Database Designer
4 weeks ago
**About Us**:
The Grand Pacific CRO team has over 25 years’ experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on meeting customers where they are and providing exactly what they need to move their products forward.
**Job responsibilities**
- Design the Electronic Case Report Forms (eCRFs) in collaboration with the Clinical Data Manager (CDM) according to clinical protocol and study data requirements.
- Develop the Clinical Database Systems for data collection (Electronic Data Capture, EDC) and supportive documents, e.g. Data Validation Specification, database testing documents, etc.
- Setup the edit checks program in Clinical Database Systems
- Support the clinical database deployment (Go-Live), including the change order management during ongoing period.
- Maintain all EDC build and EDC change order related documentation following standard practice guidelines.
- Coordinate with the Clinical Data Manager and EDC vendors to ensure study deliverables are met and the data collection activities satisfy the clinical trial regulation and requirements.
- Upload Randomisation List and Kit List into EDC
- Support external data import to EDC and data verification/reconciliation as needed.
- Provide technical support for the clinical database deployment.
- Maintain and oversee the Clinical Database Systems during the study conduct
- Support database lock procedures and archiving the study data and documents when the study is closed.
- Develop and maintain the Grand Pacific CRO library eCRFs, standard trial data management document templates and SOPs.
- Support as the Study Unblinded Clinical Data Manager (CDM) to oversee and maintain EDC.
- Maintain up to date awareness of industry regulations and guidelines (GCP-ICH, 21 CFR Part 11, HIPPA)
- Ensure data integrity across projects following applicable regulatory standards, ICH, GCP and SOP
**Qualifications
- Bachelor’s degree, or educational equivalent, in clinical, biological, computer science, health related field or computer related field with
- 2 years of experience in database development in any EDC
- Experience in managing delivery of projects independently through full data management study life-cycle
- Equivalent combination of education, training, and experience in relevant industry
- Knowledge of relational database concepts, programming, and SQL language or related programming language (such as Java Script)
- Excellent skills using Microsoft Office Suite: MS Excel, MS Word and MS PowerPoint.
- Strong communication skills in English.
- Relevant experience in clinical data management in a CRO or bio/pharmaceutical setting is desirable.
- Knowledge of 21 CFR Part 11 is requirements.
- Knowledge of CDISC/ CDASH data standards.
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