Job Description Study Builder Location: Boston, Massachusetts Date Posted: 9/8/2023 Employment Type: Permanent Recruiter: Mohamed Barami Recruiter Email: mo.barami@avidtr.com Job ID: JN -092023-15715 Job Description Study Builder The Medidata Rave Study Builder is primarily responsible for database design, setup, and maintenance of assigned clinical trials/projects in Medidata Rave.Responsibilities: Designs and develops electronic case report forms (eCRFs) to meet the data collection requirements of oncology protocols in accordance with our client's guidelines including CDASH/SDTM/CDISC standards published by NCI for use in NCTN studiesWorks closely with Data Management and Statistical staff to develop and validate eCRFs, edit checks and custom functions.Responsible for database maintenance.Reviews protocols and addenda in development.In collaboration with senior team members, coordinates interactive review meetings for assigned studies to ensure that forms reviews for assigned studies occur in a timely manner and in accordance with protocol development timelines. Quality control of study setup and validation procedures.Manage multiple priorities, assess needs and adjust workloads and communicate project status accordingly.Performs other duties as assigned. Job RequirementsExperience/Education: Experience in clinical trials data management and/or electronic data capture (EDC) systems (oncology experience a plus)Proficiency in Clinical Data Management procedures including knowledge of Good Clinical Practice (GCP) preferredStrong computer skills with proficiency in MS Office. Experience with Medidata Rave or other EDC systems preferred.Knowledge of CDISC, SDTM, CDASH a plus.Excellent written and oral communication skillsBachelor's degree from an accredited college or university or equivalent work and/or life experience. Apply for this job