Coding Specialist

Location: 

Basel Area - Allschwil, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

Job Responsibilities

 

 

  • Ensures Data Management (Biometry) activities adhere to Idorsia Standards and applicable regulations
  • Meets study timelines in terms of Data Management deliverables
  • Ensures data handling consistency within allocated study(ies)
  • Leads Data Management activities for assigned study
  • Provides input to the development of the study protocol
  • Coordinates the development of the (e)CRF in line with Idorsia standards
  • Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmers for development for the allocated study(ies)
  • Organizes, monitors and tracks data coding, data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders
  • Generates study metrics and status reports
  • Represents Data Management at Clinical Trial Team (CTT) meetings
  • Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing & vendor's management)
  • Presents study related topics at CTT, Investigators and Monitors meetings
  • Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify clinical data is handled according to protocol, applicable Quality System (QS) documents and GCP
  • Performs and/or coordinates clinical trial data coding activities according to the Idorsia standards and regulatory requirements insuring correctness and consistency
  • Produces coding listings for review by the other relevant function representatives within Clinical Development
  • Interacts with Global Drug Safety (GDS) for SAE reconciliation when needed. Advises on version of the standard dictionaries i.e. MedDRA and WHO Drug dictionary to be used
  • Plans and participates in the up versioning of the standard dictionaries, MedDRA, WHO Drug dictionary, in accordance with the regulatory requirements
  • Performs quality control to ensure correctness and consistency of the applied coding by review of coding listings

 

 

Candidate’s Requirements

 

 

  • Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
  • At least 4 years' job relevant experience in Pharmaceutical or Biotech industry within Clinical Data Management
  • Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP))
  • Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design
  • Proven experience in coding of clinical trial data
  • Good organizational and presentation skills
  • Fluent in written and spoken English

 

 

What Idorsia offers

 

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution oriented environment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous social benefits

 

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1353

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.