Site Activation Specialist I

🔥 2 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Manage Investigator Initiation Package, Investigational Product Release Form, and Activation Greenlight Form through approval, following sponsor indications and quality procedures • Manage regulatory documents including CVs, FDF, FDA 1572, and GCP trainings • Pre-fill and distribute essential documents to sites • Review and QC completed documents for consistency • Assemble study-startup packages of up to 40 documents per site for approval so sites can receive study drug and start screening • Lead and collaborate on local and central Institutional Review Board, Institutional Ethics Committee, and Central Ethics Committee activities for countries in scope • Answer queries from ethics and regulatory authorities • Manage protocol amendments and essential document updates throughout the study lifecycle • Interact with sites and site personnel to complete study documents at the expected quality

🎯 Requirements

• Strong analytical and investigative mindset with the ability to review information from multiple sources and identify potential risks • Excellent attention to detail and commitment to maintaining accuracy in documentation and data entry • Sound professional judgment with the ability to distinguish between factual findings, items of note, and potential significant or disqualifying findings • Ability to follow established processes while recognizing when escalation is required • Strong organizational and time management skills with the ability to manage competing priorities and meet deadlines • Clear written communication skills, including documenting rationale, evidence, and outcomes in a concise and traceable manner • Comfortable with repetitive work and structured processes • Able to maintain quality and focus while performing similar assessments repeatedly • Equivalent experience, skills, and/or education will also be considered

🏖️ 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