Position Overview
Our client, a specialized CRO is seeking a Clinical Data Associate to join their team, who will be responsible for maintaining and constantly improving performance and quality in data management services.
This includes but is not limited to the following activities: Database set-up, CRF tracking, review, validation and updating data in clinical databases for paper and EDC studies and assisting in development of data management-relevant study documents.
Responsibilities also include supporting other (data management) team members
Essential Job Functions CRF Tracking and scanning including set-up and testing of tracking databaseData Entry support where required and Verification of data entry discrepancies and creation data entry guidelineSupport in database set-up activities for paper and EDC studies such as creation of a CRF, set-up and testing of study databases, creation of test cases for data entry screens and plausibility checksValidation of CRF, Query and external dataCreation and management of queries related to CRF or external dataExternal data reconciliationSupport in quality control tasks for CRF dataParticipation in team and project meetingsSupport in TMF related activitiesPreparation of data management TMF parts for archivingSupport of Clinical Data ManagersProcess improvementsOptional/Developmental Job Functions SAE reconciliationUser account managementUser training and related activities for EDC studiesCreation and maintenance of external and internal training documentation for EDC studies (general and project specific)Support of eClinical Project ManagerRequirements Education or experience in the field of medical documentation or a related fieldKnowledge in GCP requirements and understanding of regulatory guidelines in drug research.Good computer skills and proficiency with data management software, MS Word, Excel and the InternetProblem solving skills and ability to work both independently and in teamsOther Skills/Abilities Sound communication skills – interpersonal and both verbal and written in EnglishA flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail