Clinical Trial Manager II

🔥 3 minutes ago

🇲🇽 Mexico – 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 focused on patient safety, protocol/GCP/regulatory compliance, and data integrity • Oversee site interactions from activation through closeout, including recruitment and investigator payments • Identify clinical trial risks and develop risk mitigations • Review study scope, budget, protocol content, and contractual obligations • Monitor operational data, metrics, reports, timelines, quality, and budget risks • 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 handoffs with Study Start Up, Patient Recruitment, and Data Management teams • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Ensure CTMS, dashboards, and other systems are configured and available, including user acceptance testing • Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines • Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks • Review monitoring documentation and ensure timely delivery to company and sponsor specifications • Provide clinical deliverable and risk status updates to clients, project management, and leadership • Support inspection readiness, corrective action plans, data cut, and database lock deadlines • Provide performance feedback to line managers • Coordinate clinical activities across complex trials or portfolios • Coach and mentor CTMs on clinical delivery, project risks, and action implementation

🎯 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 • 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