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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