Type of placement: Contract (12+ months) - Strong possibility to turn permanent
Location: Basel, Switzerland
Starting: October 2016
Setup and maintenance of the Clinical Study Databases, in tight collaboration with the Study Data Manager Develop data transformation programs, including specifications according to CDISC SDTM and company's data tabulation standards.
Provides technical coaching and mentoring for sub function activities to Assistant Clinical Programmer, and/or Associate Clinical Programmers assigned on a program Reviews and provides feedback to Scope of Work for outsourced studies with respect to the DDE sub function's areas of responsibilities collaboration with the Study Data Manager Specification creation for the conversion of the study patient data to CDISC SDTM format. User Acceptance Testing of subsequent SAS conversion programs and the CDISC SDTM domains. Creation of TIBCO Spotfire Data Cleaning reports, mainly from reports templates, according the study team needs Is responsible for performs of complex deliverables for the sub function for one or more studies Contributes or leads local and sub functional working groups and initiatives Contributes to cross-functional or global initiatives Leads or participates in the local functional/cross-functional implementation of best practices and process improvement initiatives Effectively communicates ideas, project goals and status of work and independently presents at department meetings Identifies and develops solutions to complex problems Sets targeted timeframes for deliverables and anticipates potential scenarios that may create timeline delays Able to influence and negotiate a positive outcome Evaluates probability, impact and priorities of risks and develops and implements mitigation plan May also operate as a subject matter expert for a particular task for the sub-function consistently
Qualifications and Experience:
BA/BS degree or equivalent and at least 3 years of industry related experience Good understanding of Pharma Development principles In-depth understanding of the business of his or her sub function and the greater Clinical Data Manager organization Experience working with Clinical Trial protocols, Case Report Forms (CRF) and non-CRF data Experience on the Clinical Study life cycle from eCRF design, setup, conduct to close-out Ideally experienced on using Medidata RAVE System (eCRFs, Edit checks, Custom Functions) Hands-on experience on using/creating/verifying CDISC SDTM formatted datasets SAS programming skills, Custom Function skills and/or Spotfire skills Excellent communication skills Strong team player with a driving attitude Innovative and proactive mindset Fluent English in speaking/writing Able to cope with time pressure Ability to manage multiple tasks Relevant working/residency permit or Swiss/EU-Citizenship required