Clinical Database Developer (based in Basel or Geneva)
Posted on May 1, 2021 by Helvetica Partners
For one of our client, we are looking for a Clinical Database Developer who will provide Clinical Data Management support to the Clinical Research Department in all phases of projects related to clinical development programs. Key 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. Education Qualifications 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).