CLINICAL RESEARCH SCIENTIST/ DATA MANAGER/CRA

Contract Clinical Research Scientist/ Data Manager in Wilmington, DE

Responsibilities: Coordinate operational aspects of study and lead and participate in activities that ensure quality, consistency, and integration of study data and progress SD deliverables to time cost and quality from Study Delivery Concept through database lock and study close-out activities. Implement globally agreed Study Delivery and Clinical Development strategies including process and technology related to Study Delivery. Establish and maintain key interactions with major customers (internal/external) and interface with clinical departments (e.g. CIS) to ensure quality of SD deliverables. Lead and/or participate in preparation and delivery of Study documents for example CRF, DMP, SDV plan, country specific study Management agreement for deliverables, country specific CSA, confidentiality agreements and clinical trial applications. Possibility of travel both 50% domestically and less than 20% internationally.
REQUIREMENTS
Requirement: University degree in biological science, health related field, licensed registered nurse or equivalent experience. Phase I protocol writing a must. Blend of Clin Ops and Data Management desired. Understanding of the clinical study and drug development process, GCP/ICH guidelines in relation to Study delivery operational activities.