.**Description**Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.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 accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:**WORK HERE MATTERS EVERYWHERE****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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.**Job responsibilities**- Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.- 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- Document filing for trials using a paper TMF- Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified- Maintain compliance with departmental quality, performance and utilization targets- Complete administrative tasks (e.G., status reports) as requested- Maintain compliance with company requirements (e.G., time tracking, training)- Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.- Participates in study specific training as required.- For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return