Job Description

:About the Opportunity:The Manager Centralized Document Management is primarily responsible for providing supervision and line management of clinical operations staff dealing with centralized trial master files as assigned.
The Manager will provide support to the group of Document Management Associate (DMA) in day to day activities of Centralized Document Management within the clinical team. This role will be responsible for line management and oversight for DMAs, SDMAs and CDS and working with all relevant stakeholders within project team and assisting with all management aspects for project Trial Master Files (TMF), both electronic and paper, in a format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs.Minimum Qualifications & Experience:

• At least 10-12 years of experience in clinical research across all stages and phases of trials with previous exposure to line or matrix management preferred.
• Practical experience in handling Trial Master File activities including Paper or electronic - TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.
• Line Management experience is essential.

Responsibilities:

• Act as Line Manager for assigned staff including Team Lead, Centralised Document Management, DMA, SDMA and CDS.
• Work with the Resourcing Co-ordinator to identify appropriate project assignments for direct and indirect line reports, identify shortfall in resourcing and trigger hiring requests as necessary.
• Coordinate induction process for all new line reports on commencement of employment. Ensure line reports are aware of and understand company policies and procedures appropriate to their position.
• Ensure balanced workload and project assignments in line with employees' skills and experience.
• Actively seek feedback and monitor the employee's performance metrics and KPIs, as well as the quality of their work, on an ongoing basis. Provide constructive and developmental feedback to ensure performance standards are maintained.
• Lead the team in developing all TMF-related processes, tools, training and working practices in collaboration with Senior Clinical Operations Management team.
• Provides expertise and best practices related to the TMF, including EDs, TMF processes and eTMF systems, and other clinical trial processes.
• Ensure the document quality requirements are agreed to and met by the study team, according to Completeness, Timeliness and Quality metrics.
• Responsible for ensuring projects are appropriately resourced to a DMA, SDMA, CDS.

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 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 committed to respond to every application. We look forward to connecting with 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.

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Novotech