Job Description

Reports to: Director, Data ManagementPosition SummaryThe Senior Clinical Data Manager at Fractyl Health, Inc. will be responsible for all aspects of the clinical data management activities associated with clinical database design and project oversight, resulting in quality and accuracy of the database for our clinical trial(s).Primary ResponsibilitiesResponsible for coordinating, facilitating, and participating in all data management activities from initiation of protocol, study startup through database lock with minimal oversight. Provide Data Management oversight for outsourced projects. Provide vendor management. Support CRF design, review, and validation of clinical database. Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications Perform user acceptance testing for assigned projects. Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target with project timelines. Prepare data transfer agreements & coordinate the receipt of data transfers. Author all database lock documentation for assigned projects. Prepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc. Performed ad-hoc reporting. Adverse event and concomitant medication coding using MedDRA and WHO-Drug. Responsible for SAE reconciliation. Provide data management timelines and cost associated in the project scope of work. Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed. Ability to support a number of moderate to complex trials with minimal supervision. Build successful relationships and seamless interfaces at the project team level and provide timely and effective communication to the study team, trial manager, and Biostatistics. Interface closely with Biostatistics and Project Management on the project level. Provide mentorship to junior level Data Mangers. Perform all activities in compliance with applicable regulations, Fractyl's policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.Bring a "can do" spirit to work and deliver on other responsibilities as assigned.Education or Certification RequirementsBachelor's degree in a related health profession or a field related to research compliance5+ years of data management experience in a CRO or sponsor company environmentProfessional Work ExperienceKnowledge of CDISC/CDASH standards Experience with EDC systems. Knowledge of medical terminology and use of coding dictionaries. Knowledge of ICH, FDA, and GCP regulations and guidelines related to data management. Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).Qualifications and SkillsStrong scientific background and understanding of clinical trials including pharmaceutical, device, operations, and regulatory compliance. Proven ability to take independent action to initiate process improvement, when needed. Other Essentials and Key Success FactorsSuccessful track record of working in high-growth and dynamic organizationsDemonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spiritAbility to lead fast-paced projects with a keen sense of urgency to get the job done wellEvidence of "hands-on" experience and expertiseProven and successful track record as a team-player and collaborator in small working environmentsHighly organized and detail oriented with a passion to deliver quality resultsExcellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentationHighest levels of professionalism, confidence, personal values and ethical standardsTravelThis position requires no regular travel.The description and requirements outlined above are general; additional requirements may apply. Fractyl Health, Inc

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