Pharmaceuticals & Medical Devices (Healthcare & Medical) A new opportunity to join a leading specialist life-sciences company. You will be working with cutting-edge technology and methodologies - providing an opportunity to work with the latest industry technology and advancements in the field.As a growing business, tailored progression opportunities are offered to suit individual needs with direct support from senior management to ensure healthy growth in the team.You will be joining a collaborative smaller team environment and given the full scope of responsibility of managing all data management activities, supporting the project leads, in a hands-on and client-facing role.This role will be 100% remote based in Australia.Suitable for an experienced Clinical Data Manager with experience in a CRO or similar setting.Key Responsibilities:The Clinical Data Manager will be responsible for managing all aspects of clinical trial data from study start-up through database lock. This includes developing and implementing data management plans, designing case report forms, overseeing data entry and validation, and generating study-specific data reports. The ideal candidate will be a detail-oriented, self-starter who can work independently and collaboratively in a fast-paced, small company environment.Develop and implement data management plans for clinical trialsDesign case report forms (CRFs) and review/edit CRFs created by CROs or study teamsManage electronic data capture (EDC) systems and oversee data entry and validationEnsure data quality and accuracy by conducting data review and query resolutionCreate and review data reports for clinical study team and regulatory submissionsPerform database lock and archiving activities in accordance with SOPs and regulatory requirementsContribute to the development and improvement of data management processes and proceduresCollaborate with cross-functional study teams to ensure timely and accurate data collection and reportingQualifications:Bachelor's degree in a relevant scientific discipline (e.g., biology, chemistry, statistics) or equivalent experienceMinimum of 2 years of experience in clinical data management, preferably in a CRO environmentKnowledge of ICH/GCP guidelines and FDA/EMA regulationsExperience with EDC systems and CRF design
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