Site Management Associate II – Senior SMA

🔥 2 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $70.1k - $145k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Perform site management activities in compliance with company and sponsor SOPs and work instructions • Ensure compliance with local regulations, GPP, and/or ICH-GCP as applicable • Conduct site identification, qualification, and start-up activities • Conduct remote and on-site monitoring throughout all study stages • Review Investigator Site Files and reconcile them with Trial Master Files • Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other project documents • Support subject/patient recruitment, retention, and awareness strategies • Enter data into tracking systems and resolve assigned action items • Review site data, assist with data query resolution, and follow up on missing data • Maintain accurate communication with site staff and project teams, escalating and resolving issues • Maintain clinical tracking and management systems • Train assigned sites and ensure compliance with study protocols, informed consent, data collection, and safety reporting requirements • Support audit readiness and preparation for audits and follow-up actions • Participate in investigator and sponsor meetings • Collaborate with sponsor affiliates, medical science liaisons, and local country sponsor staff • Manage site-level activities, communications, deliverables, budgets, and timelines • Identify and communicate out-of-scope activities • Attend, contribute to, and present at study and department meetings

🎯 Requirements

• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems • Previous site management (in-house, on-site, Study Coordinator) or equivalent experience • Knowledge of local requirements for Real World Late Phase study designs, Real World Research, and relevant regulations including GPP • Excellent communication, time management, organizational, documentation, and customer service skills • Excellent customer focus and ability to interact professionally with clients and study sites • Ability to work in a team-oriented and virtual team setting, as well as independently • Ability to handle multiple tasks and prioritize to achieve study timelines • Sound problem-solving and analytical skills • Excellent command of written and spoken local language, if not English, as well as English • Ability to develop good working relationships via oral communication and good phone etiquette • Ability to travel up to 60% on a regular basis depending on assignments and study phase

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive work culture • Company car or car allowance • Medical, dental, and vision benefits • Company match 401(k) • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations, when appropriate