Description About the Role The Associate Clinical Data Manager ( Randomization and Trial Supply Management) is responsible for planning, conducting and managing of all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs. Responsibilities: Develop and maintain Trial Supply Management (TSM) specifications to ensure accurate system configuration and compliance. Serve as the primary RTSM support for sites, Project Managers, and CRAs, providing guidance and resolving system-related issues. Develop and maintain Trial Supply Management (TSM) specifications to ensure accurate system configuration and compliance. Serve as the primary RTSM support for sites, Project Managers, and CRAs, providing guidance and resolving system-related issues. Perform comprehensive data management tasks including data review, query management, external data reconciliation Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required Design and review of database structure, validation rules and consistency checks. Operation of Clinical Data Management software for data entry of clinical trial results. All data cleaning/validation tasks Experience and Qualifications: Graduate in a clinical or life sciences related field. At least three to six years experience working in a Clinical Data Associate (or equivalent) role in a Pharmaceutical industry or related role. Must have Randomization and Trial Supply Management experience Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
