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Site activation specialist georgia (europe)

Sorgono
Contratto a tempo indeterminato
Buscojobs
Pubblicato il 19 agosto
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For our team in Georgia (Europe), we are currently recruiting for an experienced Site Activation Specialist. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model places the customer and the patient at the center of everything we do. We are continuously seeking ways to simplify and streamline our work to make Syneos Health easier to work with and 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 about changing 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 a total rewards program. We are committed to our Total Self culture — where you can authentically be yourself. Our culture unites us globally, and we are dedicated to caring for our people. We are continuously building the company we all want to work for and our customers want to work with. Bringing together diversity of thoughts, backgrounds, cultures, and perspectives helps create a place where everyone feels they belong. Job responsibilities Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager. Works within forecasted submission / approval timelines, ensuring compliance, tracking milestone progress in the SSU tracking system, investigating delays, providing contingency plans, and escalating issues promptly. Monitors basic financial aspects of the project and the hours / tasks available per contract; escalates discrepancies timely. Reviews and complies with SOPs and Work Instructions, keeps training records updated, and ensures timesheet compliance. Supports continuous improvement of quality in all Site Start-Up components at the country level (submissions, document collection, communication with Authorities and ECs, etc.). Ensures all relevant documents are submitted to the Trial Master File as per SOP / Sponsor requirements. Responsible for functions such as : Local Submissions Specialist : Follows project direction, serves as a contact during start-up, and prepares / submits regulatory applications. Prepares ongoing submissions, amendments, and notifications required by local authorities. Acts as liaison between investigational sites and functional leads, overseeing site activation process. Provides support with site selection, contracts, and budgets, ensuring proper documentation and negotiations. Qualifications Bachelor's Degree Detailed understanding of clinical processes J-18808-Ljbffr J-18808-Ljbffr

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