Senior Data Management Programmer
Senior Data Management Programmer
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 SeniorData Management Programmer to join our team !
- Support remote patient data monitoring workflows and data processing: work on processes, software, and infrastructure to handle data collected
- Develop review tools for patient data monitoring and provide regular outputs to clients as per Central Clinical Monitoring Plan
- Develop Database: design, create, maintain and close project and trial capture databases using paper and EDC systems
- Develop and maintain data standards (CDISC), manage ad hoc and standard reporting, develop and maintain internal documentation.
- Program data extractions, data listings for data cleaning purposes, logical checks, protocol violations, according to specifications provided by the TRIAL DATA MANAGER and in line with the quality standards
- Implement, execute, schedule procedures to manage CRF and non-CRF data
- Test the clinical databases and validation procedures
- Keep track of data management status activities on different studies
- Contribute to developing and implementing new technologies
- Assist in programming activities for Regulatory Submission (FDA filing) and Audit Requirements.
- University degree (or equivalent) in mathematics, informatics, engineering or related disciplines or high school qualification
- At least 5 years' experience in programming of which at least three in a data management function of a pharmaceutical company or a clinical research organization
- Good knowledge of programming languages and knowledge of data management principles and tools
- Experience with CTMS and understanding of LAB and other third-party data
- Experience and understanding of CDISC/SDTM standards
- Experience with Clinical Data Management System, including:
- EDC Database build, Validations/Derivations, Coding, Discrepancy Database/Querying
- Standardization modules, data reporting tools
- Develop/maintain global data standards, CDISC/STDM mapping
with expertise knowledge of at least one area mentionned above
- Good Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP) and 21 CFR Part 11
- Proficient in Microsoft Windows and Office
- Sound knowledge of clinical trial process
- Experience in maintaining and supporting data management and biostatistics processes in a distributed client base within a regulated environment
- Ability to communicate effectively in English (verbal and written) ,and to work in an agile way
- Act as a Team player
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
Business Area: Global Clinical Development - Biometry
Job Type: Permanent
Job ID: 2255
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.