Senior Clinical Trial Manager

• Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
• Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
• Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
• Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
• Focuses on investigator engagement through timely follow up with sites
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
• Contribute to site level recruitment strategy and contingency planning and implementation
• Delivers competent vendor management at the country level
• Ensures high standards for study monitoring by conducting quality local trial team meetings
• Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents
• Accountable for ensuring quality data is provided by the site and queries are resolved within expected timelines
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements
• With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits
• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals
• May contribute as a trainer of systems/processes or provide input to functional area in process initiatives
• Full utilization by timely and accurate time reporting
• Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites
• Autonomy with execution of local trial management services
• Depth of knowledge with local trial management services
• Process leadership

• BA/BS degree
• Degree in a health or science related field
• 3 - 5+ years of trial end to end management experience
• Solid Tumor Oncology experience required
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
• Strong IT skills in appropriate software and company systems
• Proficient in speaking and writing the country language and English
• Good written and oral communication skills
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Start-up & Database Locks/Cleaning experience preferred

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others