Trial Data Manager

Location: 

Basel Area - Allschwil, BL, 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.

 

We are looking for an enthusiastic and motivated Trial Data Manager to join our team !

 

Job Responsibilities

 

  • Ensures that Data Management (Biometry) activities (related to assigned study) 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 outsourced or not to external vendors (CROs, AROs)
  • Provides Data Management 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 Programmer(s) for development for the allocated study(ies)
  • Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
  • Organizes, monitors and tracks 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 partners’ management)
  • Prepares and archives Data Management study documentation
  • Presents study related topics at CTT, Investigators and Monitors meetings
  • Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management 
  • Represents Data Management in cross functional working groups related to the system/process
  • Forecasts study team resource requirements
  • Ensures Data Managers assigned to study have required training 
  • Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated and provided as per agreed timelines
  • Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handles according to protocol, applicable Quality System (QS) documents and GCP
  • Work is expected to be performed on the premises of Idorsia
  • Acts as Data Manager for studies where no DM is assigned
  • Reports to Project Data Manager assigned to the project(s) or study(ies)

 

Candidate's Requirements

 

  • Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
  • At least 3 years’ experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical
  • Data Management with good level of functional expertise in 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
  • Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study
  • 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 benefits


Work Location: Allschwil- Basel Area

Country: Switzerland

Business Area: Global Clinical Development - Biometry

Schedule: Fulltime

Job Type: Permanent

Job ID: 2307

 

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.