Clinical Trial Manager
GRAIL
Google Cloud Platform
Project Manager
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Seoul • 🇰🇷 South Korea
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Provide project management oversight, clinical monitoring, and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance, and data integrity
- Oversee site interactions post activation through site closeout, including patient recruitment and investigator payments
- Identify critical data/process and protocol execution risks and propose/implement mitigations (RACT)
- Review study scope of work, budget and protocol content and ensure clinical team awareness of contractual obligations
- Use operational data and metrics to identify risks to timelines, quality and budget and escalate as needed
- Participate and present in key meetings (eg. Kick Off Meeting) and serve as escalation point for site communications
- Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate handoffs and meet study milestones
- Develop and maintain clinical study tools and templates, and ensure CTMS/dashboards/systems setup and UAT
- Coordinate training for study team on protocol specifics, CRF completion, dashboards, SOPs and data plans
- Oversee resourcing allocations for CRAs/Central Monitors and ensure quality of monitoring and site management deliverables
- Review monitoring documentation and ensure deliverables meet company/sponsor specifications and timelines
- Provide status updates to clients, project management and leadership and support inspection readiness
- Contribute to financial/metric reporting and assist with budget/contingency planning and invoice reviews
Requirements
- Experience in project management oversight, clinical monitoring, and central monitoring deliverables
- Knowledge of protocol, GCP and regulatory compliance
- Experience overseeing site interactions from activation through closeout
- Ability to identify critical data/process risks and implement mitigations (RACT)
- Experience with CTMS, EDC, ePRO, TMF, IVRS/IWRS and central monitoring dashboards
- Experience managing and allocating CRAs and Central Monitors and overseeing site assignments
- Ability to review budgets, approve invoices and assist financial reconciliation
- Experience interacting with clients and cross-functional teams (Data Management, Study Start Up, Patient Recruitment, Medical Monitoring, Pharmacovigilance, QA)
- Experience supporting inspection readiness and facilitating team training
- Therapeutic area knowledge and ability to present at key meetings
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture – inclusive work environment
- Comprehensive resources (emerging technologies, data, science, knowledge sharing)
- Multiple career paths and employment opportunities
- Commitment to reasonable accommodations (Americans with Disabilities Act compliance)
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementclinical monitoringcentral monitoringprotocol complianceGCP compliancerisk assessment and mitigation (RACT)budget reviewfinancial reconciliationtraining coordinationdata integrity
Soft skills
communicationcollaborationproblem-solvingleadershiporganizational skillspresentation skillsclient interactioncross-functional teamworkstatus reportinginspection readiness
