Site Management Associate

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $70.1k - $126.1k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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 • Assure compliance with local regulations and applicable GPP and/or ICH-GCP guidance • Conduct site management activities according to the Scope of Work, Site Management Plan, and relevant guidelines • Identify sites and contact them regarding study participation, contact details, and required documents • Qualify and select appropriate sites for assigned studies • Perform site start-up activities with study start-up and regulatory teams • Conduct remote and on-site monitoring throughout all study stages • Review Investigator Site Files for accuracy, timeliness, and completeness and reconcile them with Trial Master Files • Document site activities and enter data into tracking systems • Support subject/patient recruitment, retention, and awareness strategies • Protect subject/patient confidentiality • Review assigned-site data, assist with data-query resolution, and follow up on missing data • Maintain timely communication with site staff and project teams and escalate issues for resolution • Maintain clinical tracking and management systems • Ensure assigned sites are trained and compliant with study requirements • Provide site and project guidance for audit readiness and support audit preparation and follow-up • Attend and participate in Investigator Meetings and sponsor meetings • Collaborate with Sponsor affiliates, medical science liaisons, and local country sponsor staff • Manage site-level activities and communications to meet project objectives, deliverables, and timelines • Identify and communicate out-of-scope activities to the Clinical Operations Lead • Attend, contribute to, and present at study and department meetings

🎯 Requirements

• Experience and expertise in site management and clinical operations • Ability to perform site management activities in compliance with Company and Sponsor SOPs and Work Instructions • Knowledge of local regulations, Good Pharmacoepidemiology Practices (GPP), and/or ICH-GCP • Ability to conduct site identification, qualification, and start-up activities • Ability to conduct remote and on-site monitoring activities through all study stages • Ability to review and reconcile Investigator Site Files (ISF) with Trial Master Files (TMF) • Ability to document activities through confirmation letters, follow-up letters, trip reports, communication logs, and project documents • Ability to support subject/patient recruitment, retention, and awareness strategies • Ability to review study data, resolve data queries, and follow up on missing data • Proficiency with hardware, software, clinical tracking, and management systems • Ability to communicate effectively with site staff and project teams and escalate issues appropriately • Ability to ensure sites are trained and compliant with study protocol, informed consent, data collection, and safety reporting requirements • Ability to support audit readiness and audit follow-up actions • Ability to understand project scope, budgets, timelines, and site-level deliverables • Ability to adapt to changing priorities • 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 and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time • Reasonable accommodations, when appropriate