Clinical Trial Manager II

🔥 29 minutes ago

🌐 Brazil, Argentina, +3 more countries – Remote

🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote 🇨🇱 Chile – Remote 🇵🇪 Peru – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.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.

Apply Now

Find Similar Remote Jobs

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 and protocol-execution risks and develop risk mitigations • Review study scope of work, budget and protocol content; ensure clinical project teams understand contractual obligations and parameters • Identify and escalate risks affecting timelines, quality, budget or contracted scope • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site staff and interact with principal investigators and other site staff by phone or in person • Collaborate with Study Start Up, Patient Recruitment, Data Management and other functional leaders to meet study milestones • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards and other systems are configured and available, including overseeing UAT and access/audit trail reviews • Coordinate training for study teams on protocols, CRF completion, dashboards, SOPs, plans and timelines • Oversee CRA and Central Monitor resourcing, site assignments and team conduct • Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables using approved systems and tracking tools • Review project oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central monitoring dashboards • Participate in development of study risk assessment plans and ensure assigned team members comply with monitoring strategies and risk plans • Review the quality and content of monitoring documentation and ensure timely delivery according to company and sponsor specifications • Interact with clients, project management, leadership and functional departments; provide status updates and solutions for protocol-execution and site-management obstacles • Support inspection readiness for clinical trial management scope • Oversee CRAs and Central Monitors, assess process/training/CMP compliance, identify emerging risks and support corrective action plans • Support activities to achieve data cut and lock deadlines • Provide performance feedback to line managers on staff strengths and development areas • 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 to identifying and mitigating potential threats to successful clinical research projects • Critical-thinking ability to determine causes and appropriate solutions when identifying issues • 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 where employees can authentically be themselves • Reasonable accommodations, when appropriate, under the Americans with Disabilities Act

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume