Clinical Trial Manager II – Sponsor Dedicated

🔥 1 minute ago

🇨🇱 Chile – 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.Why this score:

• Just posted.
• Jobs at this company usually fill in 21 days.
• No salary listed.

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 focused on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversee site interactions from post-activation through site 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 and ensure clinical project teams understand contractual obligations and parameters • Identify and escalate risks to timelines, quality, budget and contracted scope • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site staff communications and interact with principal investigators and 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 set up, available and properly maintained, including UAT and access/audit trail reviews • Coordinate initial and ongoing study-team training on protocols, CRF completion, dashboards, SOPs, plans, guidelines, data 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 site and central monitoring documentation and ensure revisions, approvals and deadlines are completed • Interact with clients, project management, leadership and functional departments; provide status updates and solutions • Support inspection readiness for clinical trial management scope • Oversee CRAs and Central Monitors, assess compliance and identify emerging risks • Develop and support corrective action plans and 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

📊 Check your resume score for this job

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

Upload Resume