Clinical Database Developer

VaudFixeChimie, Pharma, Biotechnologie2019-07-05Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Clinical Database Developer

The Role:

• The Clinical Database Developer will provide Clinical Data Management support to the Clinical Research Department in all phases of projects related to clinical development programs.

Responsibilities:

• Databases setup, testing and maintenance
• Data system compliance by following guidelines of international regulatory authorities and internal policies
• Specifications related to data management: data transfers, Data Management Plan (DMP) Data Validation Plan (DVP), internal tools
• Implementation of edit checks
• Execution of User Acceptance Tests (UAT) for electronic case report forms (eCRF) and edit checks
• Review of external data specifications
• Data transfers with other functions and CRO
• Design and development of data management tools
• Development and maintenance of procedures and working instructions necessary to support clinical data management conforming to the function quality standards and regulation in the clinical environment.

Profile:

• At least two years of clinical database development experience is required, gained in the pharmaceutical industry, CRO or Life science related industry.
• Some experience working with Oracle and clinical database applications is required.
• Knowledge of SQL, PL-SQL, SAS, VBA, Excel, Access and CDISC
• Understanding of the research environment and good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11
• Ability to prioritize multiple tasks and manage time efficiently
• Detail-oriented with excellent organizational and communication skills
• Fluency in English is required (oral and written).

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