Clinical Trial Manager I – Sponsor Dedicated
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Job Description
Clinical Trial Manager conducting clinical monitoring and site management for Syneos Health’s biopharmaceutical solutions business. Supporting regulatory compliance, data integrity, recruitment, and trial delivery.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
- Evaluate site and site staff performance and provide site-specific recommendations
- Escalate serious issues and develop action plans with project team guidance
- Verify informed consent processes, subject/patient confidentiality, safety, and clinical data integrity
- Assess site processes under Clinical Monitoring/Site Management Plans
- Conduct source document review and verify clinical data in case report forms
- Resolve queries remotely and on site within agreed timelines
- Use hardware and software for clinical project data review and capture
- Verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing, administration, and related documentation
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities through letters, trip reports, communication logs, and project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Track observations, site status, and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables, and timelines
- Liaise with project site personnel, CRAs, and Central Monitoring Associates
- Ensure assigned sites and site team members are trained and compliant
- Attend investigator, sponsor, global monitoring, and clinical training meetings
- Support audit readiness, audit preparation, and follow-up actions
- For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff
Requirements:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Ability to perform clinical monitoring and site management activities on-site or remotely
- Knowledge of local requirements for real world late phase study designs, where applicable
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture
- Diversity, inclusion, and belonging initiatives
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