Job Detail

Clinical Database Developer (based in Basel or Geneva)

Inseriert am: 06.03.2019

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Clinical Database Developer (based in Basel or Geneva)


CAREER OPPORTUNITY

Clinical Database Developer (based in Basel or Geneva)


Novimmune SA is a drug discovery and development company located in Plan-les-Ouates (Geneva) and Basel that focuses on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders, and cancer.  The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.  The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.


Novimmune is seeking 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).


Interested applicants should send their CV, motivation letter, copies of diplomas and work certificates in English to hr-recruitment@novimmune.com with a reference to the following job code in the subject line: CliDataDev-2019

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