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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate study milestones
- Promote awareness of the sponsor’s clinical pipeline and programs to trial sites, investigators, and networks
- Conduct Monitoring Oversight Visits to assess FSP CRA monitoring quality and site inspection readiness
- Execute remote or on-site site qualification and facilitate site selection
- Schedule and conduct Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs across oncology trials
- Review and approve FSP CRA Monitoring Visit Reports
- Review site and monitoring Key Risk Indicator metrics and contribute to the Study and Site Risk Assessment Tool
- Train and retrain FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents
- Perform site management and act as an escalation point for FSP CRA monitoring quality issues
- Develop or ensure implementation of site CAPA Plans and escalate issues as needed
- Ensure sites are inspection-ready and support the sponsor during site inspections
- Utilize CTMS and TMF to file documents, maintain accurate site data, and audit site TMFs as needed
- Draft, review, or contribute to Site Monitoring Plans
- Contribute to monitoring process improvement initiatives, SOPs, work instructions, job aids, and tools
- Improve site selection, monitoring, and monitoring oversight templates in Veeva CTMS and EDC
- Establish relationships with investigators, site staff, sponsor study team members, and FSP CRAs
Requirements
What you’ll need- Completion of a bachelor’s degree (scientific or clinical field) is required
- An advanced degree is preferred
- 8+ years monitoring Oncology (solid tumor) trials, with a minimum of 4 years monitoring phase I and/or Phase III Oncology, is required
- Previous experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required
- Experience utilizing Veeva CTMS and TMF is required
- Experience supporting site and/or sponsor inspections is preferred
- Experience auditing sites and TMF is preferred
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways