Clinical document specialist (novotech)

Roles and Responsibilities

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.

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.