Clinical Trial Manager II

🔥 0 minutes ago

🇧🇬 Bulgaria – 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 post-activation through site closeout, including recruitment and investigator payments • Identify clinical trial risks and propose or implement mitigations • Review study scope, budget, protocol content and contractual obligations with the clinical project team • Escalate timeline, quality, budget and out-of-scope risks to the project manager • 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 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, available and reviewed, including UAT and audit trails • Coordinate study-team training on protocols, CRF completion, dashboards, SOPs, plans and timelines • Oversee CRA and Central Monitor resourcing, assignments, conduct, quality and delivery risks • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards • Ensure monitoring strategy, CMP/SMP and risk-plan compliance • Review site and central monitoring documentation and ensure revisions, approvals and delivery deadlines are met • Provide client, project management and leadership status updates, risks and solutions • Support inspection readiness and corrective action plans • Oversee CRAs and Central Monitors, assess compliance and support data cut and lock deadlines • Provide feedback to line managers on staff performance

🎯 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 • Critical thinking to determine causes and appropriate solutions when identifying issues • Moderate travel may be required, approximately 20% • Equivalent experience, skills, and/or education will also be considered

🏖️ 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