Site Activation Manager

🔥 2 hours ago

🇬🇷 Greece – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Lead and manage customer-focused Site Start-Up deliverables within assigned projects at country, regional, or global level • Direct technical and operational aspects of Site Start-Up deliverables • Deliver activation-ready study sites on time, on budget, and in compliance with applicable regulations • Oversee Site Start-Up activities from site selection and recommendation through site activation readiness and study life-cycle maintenance • Develop Site Start-Up timelines and report progress, risks, and gaps to the project team, Project Manager, SSU Management, and Project Sponsor • Collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing • Identify and evaluate Site Start-Up and regulatory pathway issues and implement solutions • Ensure project deliverables meet internal and customer expectations, including projections, reports, updates, risk identification, mitigation, and management • Develop and maintain customer relationships • Oversee site identification and selection, regulatory activities, clinical trial agreements, investigator budgets, essential document collection, and SSU timelines • Develop and manage integrated Site Start-Up timelines and report weekly progress • Present SSU strategy and status at client meetings and communicate outcomes to project teams • Review SSU budgets, monitor project profitability, and take corrective measures when necessary • Manage scope, timelines, resources, budgets, and out-of-scope work • Prepare core submission documents and clinical trial application dossiers for amendments • Perform Regulatory Impact Assessments and oversee risk mitigation and review • Assist with Subject Information Sheet/Informed Consent Form development • Oversee collation, quality review, and submission of country-specific applications • Contribute to SSU change initiatives • Submit relevant documents to the Trial Master File according to company SOPs and sponsor requirements • Perform other assigned work-related duties

🎯 Requirements

• Bachelor’s Degree required; Higher Degree Preferred • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP • Good understanding of clinical protocols and associated study specifications • Excellent understanding of clinical trial start-up processes • Project management experience in a fast-paced environment • Good vendor management skills • Strong organizational skills with proven ability to handle multiple projects • Excellent communication, presentation, and interpersonal skills • Quality-driven in all managed activities • Strong negotiating skills • Strong problem-solving skills • Ability to provide quality feedback and guidance to peers • Equivalent experience, skills, and/or education will also be considered • Minimal travel may be required (up to 25%)

🏖️ Benefits

• 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