
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
🔥 14 hours ago
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10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
• Provide quality deliverables at the country level under oversight from the SSU Country Manager • Track submission and approval milestones in the agreed SSU tracking system and explain or escalate delays • Assist with contingency planning to mitigate timeline impact • Monitor project financial aspects and contracted hours/tasks, escalating discrepancies • Review and comply with SOPs and Work Instructions • Maintain training records and ensure timesheet compliance • Submit relevant documents to the Trial Master File • Compile and/or review essential document packages for site activation • Prepare and submit ethics committee, regulatory authority, hospital approval, ongoing, amendment, periodic, and safety submissions • Liaise between investigational sites and functional leads • Oversee the end-to-end site activation process at country/site level • Support site selection and feasibility activities • Support preparation and negotiation of investigator contracts and budgets • Perform quality control, arrange CTA execution, archive documents, and capture metadata
• Payment experience in clinical trials • Experience/skills and/or education equivalent to the listed qualifications may be considered • Ability to follow project requirements and applicable country rules • Ability to work within forecasted submission and approval timelines • Ability to track milestone progress in an SSU tracking system • Ability to monitor basic project financial aspects and contracted hours/tasks • Knowledge of and compliance with SOPs and Work Instructions • Ability to maintain training records and timesheet compliance • Ability to submit relevant documents to the Trial Master File • Experience or ability to compile/review essential document packages for site activation • Experience or ability to prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications • Ability to prepare ongoing submissions, amendments, periodic notifications, and safety notifications • Ability to liaise between investigational sites and functional leads • Ability to support site selection and feasibility activities • Experience or ability to support investigator contract and budget negotiations • Ability to perform quality control, arrange CTA execution, archive documents, and capture metadata
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate
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