Clinical Trial Manager I/II

🔥 0 minutes ago

🇭🇺 Hungary – 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

• Develop, coordinate, and implement Phase 1 clinical research studies at organizational facilities • Collaborate with principal investigators and liaise among research subjects, client teams, investigators, and clinic operations teams • Plan logistics and resource usage • Track study progress against milestones, client deliverables, budgets, and applicable regulations • 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 recruitment and investigator payments • Identify clinical data and process risks and develop risk mitigations • Review study scope, budget, protocol content, contractual obligations, and project parameters • Escalate risks affecting timelines, quality, budget, or contracted scope to the project manager • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site communications and accompany CRA team members to sites when needed • Coordinate delivery handoffs with Study Start Up, Patient Recruitment, Data Management, and other functional leaders • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards, and other systems are configured and available, including UAT and access/audit trail reviews • Coordinate initial and ongoing study-team training • Oversee CRA and Central Monitor resourcing, site assignments, conduct, compliance, and delivery risks • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards • Review site and central monitoring documentation and ensure revisions, approvals, specifications, and deadlines are met • Provide clinical deliverable and risk status updates to clients, project management, and leadership • Support inspection readiness, corrective action plans, data cuts, and database lock deadlines • Oversee assigned CRAs and Central Monitors and provide performance feedback to line managers

🎯 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 use a risk management approach to identify and mitigate potential threats • Critical thinking 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 company culture • Reasonable accommodations for applicants and employees with disabilities, when appropriate