Clinical Database Builder

vor 2 Wochen

Newcastle City Council, Österreich Planet Pharma Vollzeit

Clinical Database Builder / Database Manager As a Clinical Database builder / Clinical Data Manager, you'll have the opportunity to design and build Clinical Databases using Viedoc & RAVE. You'll manage end‑end data projects from database set up through to database lock for Phase I‑III Oncology trials If this sounds interesting please get in touch today Responsibilities Design, build, and maintain clinical trial databases, including database builds using Viedoc. Program and configure EDC systems to support efficient data capture and validation. Develop data entry guidelines, validation rules, and quality control procedures. Review protocols and provide input on data management components. Author Data Management Plans (DMPs), Casebook Completion Guidelines (CCGs), and SOPs. Ensure compliance with GCDMP and regulatory standards (FDA, EMA, ICH‑GCP). Collaborate with biostatistics, clinical, and project teams to deliver clean, reliable data. Manage CRFs, validation specs, and database lock processes. Liaise with vendors and sponsors on data deliverables and reporting. Support EDC setup, testing, and maintenance. Perform ongoing data cleaning, edit checks, and generate listings/reports. Qualifications Bachelor's or Master's in Life Sciences, Clinical Research, or related field. 3–5 years of clinical data management experience, ideally in a CRO. Proficiency with EDC systems (Viedoc, Rave) and database build experience. Strong knowledge of regulatory guidelines and clinical trial processes. Excellent organizational, analytical, and communication skills. Ability to manage multiple projects in a fast‑paced environment. People management experience is a plus. Radiopharma trial experience is welcome but not essential. Duration Permanent, full‑time Salary Attractive salary + super Location Candidates to be based fully from home anywhere in Australia. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Health Care Provider Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion / belief, sexual orientation or age. To Apply Please click 'apply' or contact Sam Chapple (Associate Director, Recruitment – APAC) at Planet Pharma for more information: T : +61 (0) LinkedIn : #J- #J-18808-Ljbffr

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