Senior Document Management Associate Novotech

2.0 - 6.0 years

0 Lacs

karnataka

On-site

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.,

Posted 5 days ago

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Senior Document Management Associate Advanced Clinical

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Senior Document Management Associate (DMA) at Advanced Clinical, you will play a crucial role in the maintenance of the Trial Master File (TMF) to ensure the smooth conduct of clinical trials. Your responsibilities will include creating study-specific TMF Plans and Indexes, processing TMF documents according to industry standards, conducting TMF Reviews, and providing internal and external TMF training. You will collaborate closely with the TMF Manager to develop TMF Plans and Indexes, process TMF documents by classifying them, indexing metadata, and performing Intake QC reviews. Additionally, you will conduct TMF Reviews as per the TMF Plan, address missing documents, and follow up on pending tasks. Communication of TMF status and issue reporting to the TMF Manager will be key aspects of your role. To excel in this position, you should have at least an Associate or Bachelor's Degree, or a relevant combination of education and experience. Professional training in regulatory document collection and review is preferred, along with a solid understanding of the CDISC TMF Reference Model filing structure. A minimum of three years of industry experience in working with clinical trial documentation is required, and familiarity with Veeva Vault or other eTMF systems is advantageous. The ideal candidate will possess exceptional organizational and time management skills, a keen eye for detail, and the ability to maintain productivity and quality in a regulated environment. Proficiency in Microsoft Office suite, strong computer acumen, and knowledge of clinical trial applications are essential. Understanding of essential document regulations such as ICH/GCP, Good Documentation Practice, and Good Clinical Practice will be necessary for this role. At Advanced Clinical, we value diversity and inclusion as integral components of our organization. We are committed to fostering a workplace that is inclusive, welcoming of diverse perspectives and experiences, and appreciative of varied backgrounds. We encourage individuals from different cultures and backgrounds to join us in our mission to provide exceptional services to our clients. Advanced Clinical is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants. We believe in treating all individuals fairly and with respect, regardless of their race, gender, age, religion, disability, or any other characteristic protected by law. If you require any accommodations due to a disability or handicap, please inform your Recruiter so that we can discuss suitable alternatives.,

Posted 1 week ago

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