Syneos Health · SerbiaPrepare for this interview
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TMF Specialist II ** Hybrid SERBIA ** Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Job Description Core Responsibilities - Process study documentation in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and executed study-specific processes/requirements.- Support the set-up, maintenance, and closure of TMF repositories. - Support documentation collection activities, including: Document scanning and indexing for trial using an electronic TMF. Ensures the security and compliance of all documents related to active and archived projects. - Perform Quality Review of documents submitted to the TMF. - Perform Completeness Review of TMF content against Expected Document Lists to determine missing TMF content. - Paper Document and Document Control Room (DCR) Management: Perform Scanning, indexing and Quality Review and Filing of Hard copy documents Process requests for Hardcopy documents, ensuring timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures all applicable paperwork is completed upon release and return of each project document and/or project file from the DCR. Ensures the DCR is kept tidy and in an inspection ready state at all times. - Liaise with document owners to resolve any issues identified. - Escalate issues to the TMF Lead as required and Complete administrative tasks (e.g., status reporting) as requested. - Participate in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments. - Participate in process and study specific trainings as required. - Maintain compliance with company standard requirements (e.g., time tracking, training), as well as role-specific requirements (e.g. Quality, Productivity, utilization) - Create and cross reference compliance tools/trackers that have been developed to complete compliance check. - Add placeholders for missing documents. - Ability to work with limited supervision. - Perform other work-related duties as assigned. Occasional travel may be required (up to 10%).
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