
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 oversight of country-level deliverables under the SSU Country Manager • Track submission and approval milestones in the agreed SSU tracking system in real time • Provide rationale for delays, assist with contingency plans, and escalate issues • Monitor project financial aspects and contracted hours/tasks; escalate discrepancies • Review and comply with SOPs and WIs; maintain training records and timesheet compliance • Submit relevant documents to the Trial Master File • Compile and/or review essential document packages for site activation • Collect essential documents from sites when required • Prepare and submit ethics committee, 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 site activation process at country/site level • Support site selection and feasibility with the site selection lead and PM/SAM • Support investigator contract and budget negotiations, CTA execution, document archival, and metadata capture
• Equivalent experience, skills, and/or education will also be considered • Must follow project requirements and applicable country rules • Must work within forecasted submission/approval timelines • Must comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) • Must maintain updated training records and ensure timesheet compliance • Must ensure relevant documents are submitted to the Trial Master File (TMF) according to Company SOP/Sponsor requirements • Ability to prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications as required • Ability to prepare ongoing submissions, amendments, periodic notifications, and safety notifications according to local rules • Ability to support site selection and feasibility activities • Ability to assist with country template contracts, site-specific contracts, budget and contract negotiations, CTA quality control, execution, archival, and metadata capture
• 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, for employees or applicants with disabilities
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