Senior Document Management Associate

The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews. Minimum Qualifications & Experience: - At least more than 2 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. Responsibilities: The Senior DMA will have a dual responsibility of working on document upload and document QC processes. They will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader: - Receive all study documentation for assigned projects and set up, receive, track and maintain electronic or paper TMFs according to requirements. - Use all required study systems to ensure proper filing of study documents throughout the entire study. - Review each document for completeness and quality, working with the project team to ensure high-quality study documents. - Provide reports on study document quality and collection practices, ensuring timely collection of all documents. - Prepare the TMF for delivery at study closeout and for audits and TMF reviews. - Resolve any internal quality control findings and audit findings. - Create checklists and daily quality control schedules, and perform other special projects related to the TMF. - Adhere to company processes, SOPs, and relevant guidance, contributing to the development of clinical processes and SOPs. - Understand the responsibilities of Novotech as a service provider and maintain a positive professional image of the company in all communications. SDMA as a QC reviewer: - Work closely with Central Filing Team Lead for assignment of projects for QC review. - Ensure all assigned project QC reviews are performed as per the study plan. - Prepare a QC checklist and share with the project team to resolve and track any queries. - Ensure all queries are responded to within the stipulated timeline. Novotech is committed to providing an inclusive work environment where everyone is treated fairly and with respect. Team members are supported with flexible working options, paid parental leave, wellness programs, and ongoing development programs. Novotech values diversity and encourages applications from individuals passionate about clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or have caring responsibilities. Novotech is a Circle Back Initiative Employer and commits to respond to every application positively.,