Associate Clinical Data Manager

The core responsibility for this position is as a member of Novotech’s Data Management group. The Associate Clinical Data Manager’s (ACDM’s) role is to control all aspects of data management under the guidance of a (senior) CDM and/or Line Manager and to ensure compliance with Good Clinical Data Management Practices (GCDMP). Minimum Qualifications & Experience 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. 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. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated. Participates in project team meetings as required. Input into the preparation of RFP’s in liaison with BD and the clinical team. Liaison with the project team and client for preparing and maintaining Data Management Plans. Responsible for all aspects of data management including: Design and review of database structure, validation rules and consistency checks. Operation of Clinical Data Management software for data entry of clinical trial results. Development of all key Data Management Documents. Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stakeholders. Liaison with external service providers on Data Management projects as appropriate. Assist in the development of protocols as required. Perform accurate study financial projections and maintain monthly project financials. Ensure changes in scope are identified and actioned accordingly. Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general. Participation in industry forum (conferences, professional association committee work etc) as a means of professional development as well as promotion of Novotech’s image in industry. Perform comprehensive data management tasks including data review, query management, external data reconciliation. Supervision and training support for junior and contract Data Management staff as required. Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities. Identification of and participation in process improvement initiatives, as required. Provide expert assistance and input into internal cross‑functional projects including clinical research and regulatory affairs, as assigned. Project management of internal IT‑based company projects as assigned (e.g. intranet development, client database applications etc.). Benefits 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 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 contacting you regarding your application. 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. Job Info Job Identification 3432 Job Schedule Full time Locations 27F Podium West Tower, The Podium, ADB Avenue, Manila, 1550, PH #J-18808-Ljbffr