Clinical Trial Manager II, Regulatory Experience

🔥 17 hours ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 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

• Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversee site interactions from activation through closeout, including patient recruitment and investigator payments • Identify critical data, process risks, protocol execution risks and risk mitigations • Review study scope, budget and protocol content and communicate contractual obligations to the clinical project team • Identify and escalate risks to timelines, quality, budget and contracted scope • Propose and implement risk mitigations • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site communications and interact with principal investigators and site staff • Coordinate delivery handoffs with Study Start Up, Patient Recruitment and Data Management • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards and other systems are configured and available, including user acceptance testing and access/audit trail reviews • Coordinate training for study teams on protocols, CRFs, dashboards, SOPs, plans and timelines • Oversee CRA and Central Monitor resourcing, site assignments and study team conduct • Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards • Oversee compliance with monitoring strategies, CMP/SMP and risk plans • Review monitoring documentation and ensure revisions, approvals and deliverables meet company and sponsor specifications • Interact with clients and functional departments and provide status updates on deliverables and risks • Support inspection readiness for clinical trial management scope • Oversee CRAs and Central Monitors, assess compliance and emerging risks, and support corrective action plans • Support activities to achieve data cut and lock deadlines • Provide staff performance feedback to line managers • May be assigned to larger, more complex trials

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Demonstrated ability to lead and align teams in the achievement of project milestones • Demonstrated capability of working in an international environment • Demonstrated expertise in site management and monitoring (clinical or central) • Preferred experience with risk-based monitoring • Understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills • Good communication, presentation and interpersonal skills among project team and with sites • Strong conflict resolution skills • Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach • Critical thinking to determine causes and appropriate solutions • Moderate travel may be required, approximately 20%

🏖️ 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