Clinical Document Specialist

The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects. This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF) The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to Novotech SOPs. This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs

Responsibilities

• CDS will perform the responsibilities of the SDMA (refer to job description) to the highest competency and act as both a document uploader and QC reviewer.
• CDS is responsible to liaise directly with the client/alliance partner counterpart (if assigned) with respect to assigned responsibilities.
• CDS will contribute to maintenance and delivery of team Training Programs and serve as a trainer/mentor to new team members.
• Identify, develop and lead potential TMF process improvements which can improve centralised workflows and drive efficiencies across Novotech.
• May undertake line management responsibilities of the DMA team as required to assist the Clinical Operations Management team.
• CDS maintains an understanding of applicable regulatory requirements and changes with TMF Management requirements and keeps Novotech tools and processes updated accordingly.
• CDS may lead the development of the assigned project Filing Plan with Team Lead/Project Manager.
• Involved in assessing overall customer satisfaction for all studies with the central filing function, working with internal and external customers to resolve issues and ensure all SOP requirements are delivered.
• Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance.
• In collaboration with Clinical Operations Management team, assist with review and maintenance of Clinical Operations TMF processes, tools and SOPs as requested.
• Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role.
• Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
• Minimum Qualifications & Experience:
• Minimum Bachelor’s Degree with concentration in Life Sciences.
• At least 5 years of experience in a clinical research organization or equivalent role.
• 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.
• Have good knowledge of eTMF systems.

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.

• CDS will perform the responsibilities of the SDMA (refer to job description) to the highest competency and act as both a document uploader and QC reviewer.
• CDS is responsible to liaise directly with the client/alliance partner counterpart (if assigned) with respect to assigned responsibilities.
• CDS will contribute to maintenance and delivery of team Training Programs and serve as a trainer/mentor to new team members.
• Identify, develop and lead potential TMF process improvements which can improve centralised workflows and drive efficiencies across Novotech.
• May undertake line management responsibilities of the DMA team as required to assist the Clinical Operations Management team.
• CDS maintains an understanding of applicable regulatory requirements and changes with TMF Management requirements and keeps Novotech tools and processes updated accordingly.
• CDS may lead the development of the assigned project Filing Plan with Team Lead/Project Manager.
• Involved in assessing overall customer satisfaction for all studies with the central filing function, working with internal and external customers to resolve issues and ensure all SOP requirements are delivered.
• Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance.
• In collaboration with Clinical Operations Management team, assist with review and maintenance of Clinical Operations TMF processes, tools and SOPs as requested.
• Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role.
• Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

• Minimum Bachelor’s Degree with concentration in Life Sciences.
• At least 5 years of experience in a clinical research organization or equivalent role.
• 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.
• Have good knowledge of eTMF systems.