Job Description

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About The Role:
The Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point of The Trial Master File (TMF) Specialist will serve as a subject matter expert and primary point of contact for activities associated with ensuring the TMFs meet all applicable Good Clinical Practice (GCP) guidelines, regulatory requirements and Standard Operating Procedures (SOPs). Oversee end to end TMF management and support cross functional TMF users including driving innovative solutions related to trial master file management and TMF system usage. Collaborate with internal stakeholders to manage study specific TMF structure, system integrations and upgrading needs as required.
Minimum Qualifications & Experience:
Graduate in clinical or life sciences with at least 3 years of TMF management experience including experience in study start-up, maintenance and close-out, and performing quality and completeness reviews.
Subject Matter Expert knowledge of clinical trial documentation, DIA TMF Reference Model, clinical trial activities and related terminology. Detailed understanding of (e)TMF systems, principles, practices, and workflows plus being capable of working with a variety (e)TMF systems.
Experience with coordinating document management activities performed by internal teams and developing SOPs for TMF Management.
Responsibilities:
Lead the TMF strategy including development and maintenance of internal TMF SOPs and study processes; ensuring a TMF plan is in place for all studies.
Subject Matter Expert for the TMF and lead internal document management activities in accordance with Novotech SOPs.
Participate in the eTMF team including vendor management, contract oversight, monthly financial tracking and reporting and system administration.
Work with functional groups to support, facilitate, train, and review filing of TMF documents and processes.
Assist with the development, implementation, and maintenance of the Trial Master Files (TMFs) to meet regulatory requirements.
Support the TMF Management requirements to ensure TMF's are always "inspection ready" by liaising with key stakeholders including QA.
Ensure optimal use of eTMF functionality by analysing project and industry best practices and transferring manual processes into automated workflows, as possible.
Generate and deliver TMF performance metrics and compliance reports to ensure adherence to company policies.
Design and/or delivery training on TMF requirements and processes.
Actively involved and/or leads department and business improvement initiatives for the TMF.
Adhere to Company policies, procedures and guidelines and be quality minded in performance of duties.
Participate in activities of the clinical operations group, including coordination of and presentation at clinical team meetings.
Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry.
Ensure all communications with external parties and the performance of the study team presents a positive professional image of the company.
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 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.

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Skills Required