
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ 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.
đĽ 0 minutes ago
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ 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.
⢠Support site and investigator evaluation activities ⢠Collect, review, and assess regulatory, compliance, quality, and performance information ⢠Support site selection, study start-up, and ongoing study delivery ⢠Identify potential risks and escalate concerns ⢠Collaborate with internal stakeholders to ensure timely resolution ⢠Follow project direction from the designated country start-up advisor and Site Activation Manager ⢠Compile and/or review essential document packages for site activation ⢠Collect essential documents from sites ⢠Prepare and submit central and local ethics committee applications, regulatory authority applications, and other local approval submissions under supervision ⢠Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required ⢠Liaise between investigational sites and functional leads ⢠Oversee the end-to-end site activation process at country and site level ⢠Support site selection based on clinical trial requirements ⢠Assist with country-template and site-specific contracts and budgets ⢠Support contract and budget negotiations under supervision ⢠Assist with quality control, execution of clinical trial agreements, document archival, and metadata capture
⢠Strong analytical and investigative mindset ⢠Ability to review information from multiple sources and identify potential risks ⢠Excellent attention to detail ⢠Commitment to accuracy in documentation and data entry ⢠Sound professional judgment ⢠Ability to distinguish factual findings, items of note, and potential significant or disqualifying findings ⢠Ability to follow established processes and recognize when escalation is required ⢠Strong organizational and time management skills ⢠Ability to manage competing priorities and meet deadlines ⢠Clear written communication skills ⢠Ability to document rationale, evidence, and outcomes concisely and traceably ⢠Comfortable with repetitive work and structured processes ⢠Ability to maintain quality and focus while performing similar assessments repeatedly ⢠Equivalent experience, skills, and/or education will also be considered
⢠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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