Clinical Trial Manager, Regulatory Experience
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Job Description
Clinical Trial Manager overseeing site monitoring, regulatory compliance, and clinical data quality for Syneos Health’s biopharmaceutical research services. Supporting trial delivery, audits, recruitment, and site teams.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
- Ensure regulatory, ICH-GCP/GPP and protocol compliance
- Evaluate site and site staff performance and recommend site-specific actions
- Verify informed consent processes and protect subject/patient confidentiality
- Assess subject/patient safety, clinical data integrity, protocol deviations/violations and pharmacovigilance issues
- Conduct source document review and verify clinical data entered in CRFs
- Resolve queries remotely and on site within agreed timelines
- Support clinical project data review and capture using available hardware and software
- Verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document activities through letters, trip reports, communication logs and project documents
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, ongoing status and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables and timelines
- Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant
- Attend investigator and sponsor meetings, global monitoring/project meetings and clinical training
- Support audit readiness, audit preparation and follow-up actions
- For Real World Late Phase: provide site support through 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
- Working knowledge of relevant regulations and company SOPs/processes
- For Real World Late Phase: knowledge of local requirements for real world late phase study designs
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-focused workplace
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