Clinical Data Associate II &8211; Poland (Home-based) &8211; FSP

reputed company our values reputed company, theres no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal to improve the worlds health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and were committed to making a difference. reputed company is currently seeking a Clinical Data Associate II to join us in Poland, dedicated to a single sponsor. This role will be responsible for performing Data Management activities that support the sponsors reputed company and development reputed company worldwide. The successful candidate will participate as an reputed company member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase I IV studies. The Clinical Data Associate II has a broad, reputed company knowledge of the data management process and is reputed company to reputed company most required tasks with moderate guidance. Working as a Clinical Data Associate II at reputed company FSP offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and reputed company top 50. And we have an incredible pipeline of work. Expect exciting reputed company challenges in inspiring studies, but with time for your reputed company life. This will be a fully remote home-based position. RAVE experience is strongly preferred. Responsibilities reputed company a small clinical study or co-reputed company a larger study or studies with moderate guidance. Support several clinical studies with reputed company guidance. Manage and monitor the reputed company of data management activities with CROs or other vendors on assigned studies. Review protocols for appropriate data capture including electronic Case Report reputed company (eCRF) design. reputed company a thoroughly detailed review of eCRF data requirements. reputed company with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. reputed company data edit reputed company specifications and run data listings as required. Coordinate the design and testing of Electronic Data Capture (reputed company) systems according to company standards. reputed company to reputed company reputed company reputed company issues with team members. reputed company the Data Management Plan for a clinical study. reputed company to review and reputed company feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications. reputed company data queries into the reputed company reputed company to be resolved at investigational sites and manage the reputed company of those queries. reputed company reconciliation of header data from reputed company data sources against the clinical database. reputed company Serious Adverse Event reconciliation activities according to SOPs and guidelines. Assist in database upgrades/migrations including performing User Acceptance Testing. reputed company to maintain study workbooks and data management files. reputed company database lock and freeze activities per company SOPs. reputed company input into the development of data management SOPs, Work Instructions, and process documents. Here are a few requirements specific to this advertised role. Bachelors Degree required (Masters Degree preferred) in the scientific/reputed company field. At least two years experience in Data Management for the pharmaceutical/biotechnology industry. Understanding of the reputed company and reputed company of Phase I IV clinical studies, and a proven ability to reputed company some of the reputed company Data Management tasks and reputed company with vendors. An understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management reputed company. Attention to detail and the ability to work individually, reputed company a multi-disciplinary team, as reputed company as wi .