
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.
🔥 0 minutes 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 country level under oversight from the SSU Country Manager • Track submission and approval milestones in the agreed SSU tracking system in real time • Explain delays, assist with contingency plans, and escalate issues • Monitor project financial aspects and available contract hours/tasks • Review and comply with SOPs and Work Instructions; maintain training records and timesheet compliance • Submit relevant documents to the Trial Master File • Compile and review essential document packages for site activation • Collect essential documents from sites when required • Prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications • Prepare ongoing submissions, amendments, periodic notifications, and safety notifications • Liaise between investigational sites and functional leads • Oversee the end-to-end country/site activation process • Support site selection and feasibility with the site selection lead, PM, and SAM • Support country template contracts, site-specific contracts, budget and contract negotiations, CTA quality control, execution, archival, and metadata capture
• Experience with US site activation is indicated by the role title, but no specific minimum experience is stated • Ability to provide quality deliverables at country level under oversight from the SSU Country Manager • Ability to follow project requirements and applicable country rules • Ability to meet and track submission and approval timelines • Ability to monitor project financial aspects and contract hours/tasks • Compliance with SOPs, Work Instructions, training records, and timesheets • Ability to submit relevant documents to the Trial Master File (TMF) • Ability to compile and/or review essential document packages for site activation • Ability to prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications under supervision • Ability to prepare ongoing submissions, amendments, periodic notifications, and safety notifications according to local rules • Ability to facilitate communication between investigational sites and functional leads • Ability to oversee the end-to-end site activation process at country/site level • Ability to support site selection and feasibility activities • Contract and budget negotiation support experience or capability • Equivalent experience, skills, and/or education will be considered
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity and employee wellbeing • Inclusive workplace emphasizing diversity, belonging, and varied perspectives
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