Senior Clinical Trial Manager / Clinical Trial Manager II. Regional and/or Global experience. S ...

Updated: Yesterday
Location: Bloemfontein, EC, South Africa
Job ID:

Syneos Health is a fully integrated life sciences services organization dedicated to accelerating customer success across the drug development continuum. We partner with innovators at every stage-from early research to commercialization-to navigate complexity, anticipate change, and bring therapeutic solutions to patients worldwide. Our Clinical Solutions team applies a drug development mindset and deep expertise to understand customer needs and translate them into actionable solutions.

• Serve as the clinical functional lead for assigned studies, providing leadership, mentoring, and technical support to Clinical Operations teams to ensure compliance with the monitoring plan and timely, high quality deliverables within budget.
• Oversee site management, clinical monitoring, and central monitoring, ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Coordinate and monitor site activation, patient recruitment, investigator payments, and other post activation activities through close out.
• Identify critical data and process risks, develop mitigation strategies, and drive risk assessment and categorization (RACT) activities.
• Review study scope, budget, and protocol, ensuring the clinical project team is aligned with contractual obligations and parameters.
• Use operational data, metrics, and reports to assess risks to deliverables and escalates issues to the project manager.
• Implement risk mitigations, participate in key meetings (e.g., Kick Off), and serve as escalation point for investigator site communications.
• Collaborate with functional leaders (Study Start Up, Patient Recruitment, Data Management) to coordinate hand offs, meet site activation, enrollment, and database lock milestones.
• Develop and maintain clinical study tools and templates (e.g., Clinical Monitoring Plan) and ensure CTMS, dashboards, and other systems are operational and compliant with audit requirements.
• Coordinate training on study protocol, case report forms, dashboards, SOPs, and timelines for the study team.
• Manage resource allocations for CRAs and Central Monitors, oversee site assignments, and identify delivery or quality risks.
• Maintain quality of monitoring deliverables, utilizing approved systems and tracking tools to reflect timely operational execution.
• Review dashboards and clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS) to monitor site and patient activities and ensure accurate data capture.
• Participate in the development of study risk assessment plans, ensuring team members understand and implement the monitoring strategy.
• Ensure site and central monitoring documentation is complete, compliant, and reflects risks to protocol, patient safety, or data integrity, documenting revisions in CTMS.
• Provide status updates to clients, project management, and leadership on deliverables and risks, offering solutions to obstacles.
• Support cross functional compliance and delivery by demonstrating understanding of roles such as data management, study start up, and pharmacovigilance.
• Support Inspection Readiness for the clinical trial management scope and oversee training compliance for CRAs and Central Monitors.
• Provide coaching and mentorship to CTMs on functional delivery, risk evaluation, and action implementation.

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
• Proven ability to lead and align teams to achieve project milestones.
• Experience working in an international environment.
• Expertise in site management and monitoring (clinical or central).
• Preferred experience with risk based monitoring.
• Understanding of clinical trial financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
• Strong computer skills and ability to use CTMS/EDC systems.
• Excellent conflict resolution and problem solving skills with a risk management approach.
• Strong critical thinking abilities to identify issues and determine appropriate solutions.
• Moderate travel may be required (approximately 20%).

Over the past 5 years, we have worked with 94% of all novel FDA approved drugs and 95% of EMA authorized products, supporting more than 200 studies across 73,000 sites and 675,000+ trial patients.

Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, or education will also be considered. The Company complies with all applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, and provides reasonable accommodations as appropriate.

Syneos Health (Nasdaq:SYNH) is a leading integrated biopharmaceutical solutions organization accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes. We support a diverse, equitable, and inclusive culture.