Overview Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients, we expand our global reach while offering a personalized approach to sponsors and delivering value. The data management group at Peachtree has been the backbone of the company since its inception. We are looking to add an experienced Clinical Data Manager (CDM) to a very high-performing team. The CDM is responsible for all data management activities associated with the acquisition, documentation, review, cleaning and processing of clinical data in clinical trials. Responsibilities As a member of the clinical study team, relay information regarding data management status, knowledge regarding area of discipline, and timelines affecting Data Management deliverables. Ensure the Case Report Form is designed according to the Clinical Protocol, utilizing Data Standards where possible, and document deviations, if necessary. Create the Data Management Plan, Data Cleaning Plan, Quality Control Plan, and Data Management Report while ensuring consistency with the Clinical Trial Protocol and in compliance with internal or sponsor procedures, international or national regulations and Good Clinical Practices. Project, plan, develop, implement and deliver quality results in a timely manner using facts, data, measurements and a systematic approach, accomplished by: Interpret the Clinical Protocol to ensure the accurate and efficient design of the CRF. Analyze metrics surrounding the activities associated with the acquisition, documentation, review, cleaning and processing of clinical data. Interpret study timelines and prioritize workload appropriately. Assist with Clinical Data Associate activities during times of peak workload. Experience / Qualifications Clinical Data Management experience in a CRO. Working knowledge of medical terminology, federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices. Excellent communication, organization, and problem solving skills. Ability to work independently, as well as handle multiple diverse projects simultaneously, under tight time constraints. Ability to engage and demonstrate cooperative behavior to support team efforts. Experience in responding rapidly to changing priorities and in managing aggressive deadlines. Benefits Medical, Dental, Vision, Life, Disability coverage. 20 days PTO + PTO rollover + 13 paid holidays. 401(k). Employment details Seniority level : Mid-Senior level Employment type : Full-time Job function : Health Care Provider Industries : Hospitals and Health Care We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Peachtree BioResearch Solutions a Julius Clinical Company
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