The Senior Clinical Data Manager (Sr. CDM) is responsible for data management
activities across multiple studies. The Sr. CDM will report to the Manager, Clinical
Data Management and will work closely with a cross-functional team in a fast-paced
environment.
The Sr. CDM is responsible for leading the end-to-end data management activities
and associated deliverables for clinical trials, including study set-up, conduct and
close-out, standards development and GCP compliance.
This is a direct, hands-on role and the main requirement is to perform, as well as manage, all day-to-day data management activities. Other responsibilities include, but are not limited to:
• 9+ years data management experience and B.S./B.A. in a science or technical discipline degree. • Previous CRO experience is strongly recommended.
• Proficient in MS Excel. • Ability to program in SQL or SAS desirable, but not required. • Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Medidata Rave EDC, Medrio eClinical and Clario EDC experience are preferred, but not required.
• Excellent oral and written communication skills.
• Ability to work in a collaborative and multi-disciplinary environment.
• Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines.
• Availability to travel for clinical team meetings and/or Investigator Meetings if needed.
• Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
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