Location: Basel
Contract duration: 1 year
Responsibilities
* Operate as the core representative for Clinical Data Management on the study team and to be accountable for collection
* Review and management of data and ensure deliverables are met
* Leads the CDM study team and maintains oversight of all build, conduct and close activities for one or more studies, ensuring fit for purpose quality.
* Implements study conventions, processes, knowledge sharing and best practices on assigned study(s)
* Actively contribute to EDC system programming and maintenance. BA/BS degree or equivalent and moderate industry-related experience.
* Practical and theoretical expertise within his or her sub function.
* Programming and system development expertise required. In-depth understanding of the business of his or her sub function and the wider CDM organization.
Requirements
* A BA/BS degree (or equivalent) coupled with industry experience (3-5 years) in a clinical research environment.
* In-depth understanding of CDM business processes and how they align with global regulatory requirements (GCDMP, ICH-GCP, etc.).
* Expertise in ensuring data is "analysis-ready," requiring a theoretical and practical grasp of data flow from collection to submission.
* Proficiency in programming (e.g., SQL, SAS, or Python) to collaborate effectively with IT and drive system enhancements.
* Experience acting as the Primary Point of Contact (POC) & Leadership for CDM in cross-functional settings.
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