Associate Clinical Data Manager

About the Role As a member of the project team reporting to the Biometrics Project Manager the Associate Clinical Data Manager 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 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 Perform comprehensive data management tasks including data review query management external data reconciliation 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 Development of all key Data Management Documents Liaison with client companies monitoring staff as appropriate ensuring effective study communication with internal and external stake holders Liaison with external service providers on Data Management projects as appropriate Assist in the development of protocols as required 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 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 About Us Novotech is a global full-service clinical Contract Research Organization CRO Headquartered in Sydney Australia Novotech has 34 offices across Asia-Pacific North America and Europe Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments ethics committee and regulatory submissions data management statistical analysis medical monitoring safety solutions central lab services report write-up to ICH requirements project and vendor management Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System Together with the ISO 9001 Quality Management system Novotech aims at the highest IT security and quality standards for patients and biotechnology companies About the Team At Novotech we have advanced therapeutic and regulatory expertise the ability to execute across markets and a client-centric service model so that our clients get a trusted long-term partner and an accelerated path to bring their life-changing advances to market This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture whilst working with clients on the cutting-edge of life sciences At Novotech you will work alongside empowered teams with a shared commitment to success Strategic vs transactional mindset Ability to gain insights and make proactive decisions quickly Culture that fosters partnership and collaboration where every voice is heard and valued Ongoing support from senior stakeholders and leadership team