Clinical Trial Manager at ICON plc

Responsible for leading Local Study Teams within country, in order to effectively deliver on Clinical Studies(Oncology) with regards to budgets, resources, ICH-GCP guidelines and local regulations. Will ensure that all sites are identified, qualified, initiated, monitored and closed out. Will be responsible for all study timelines, commitments and the delivery of quality and timely data.

• Leading of all local study teams, optimize performance, ensuring compliance with local regulations and ICH-GCP.
• Ensuring that all feasibilities are performed at maximum quality standards.
• Coordination of site selection through site and investigator identification, performing of Site Quality Risk assessments and SQV’s.
• Ensuring of all timely submission, collection and verification of all documentation throughout the study: Namely, Financial Study agreements, budgets, Master CSA, MICF, and ICF’s.
• Setting up of CTMS at study country leve
• Overseeing, maintenance, and coordination of all monitoring activities from activation to close-out.
• Consistent development and review of risk management planning, managing sites, stakeholders, vendors, and customers to ensure all risks are mitigated.
• May be required to provide co-monitoring support, and training visits with CRA’s and review of monitoring visit reports.
• Contribution to recruitment strategies for patients, and conducting regular communication with Investigators.
• Ensuring that strong relationships are created and maintained with Local team, site staff and stakeholders globally.
• Consistent progress reporting to Global Leads and teams.
• Leading of all Investigator meetings.
• Forecasting of study timelines, resources, recruitment, budgets, and drug supplies.
• Ensuring that all systems are updated and access is granted at country level.
• Ensuring that payments are accurate and performed according to regulations and agreements
• Training and coaching of members of the Local Study Team ensuring compliance
• Ensuring documentation is completed and ready for inspection
• Leading and planning of all activities associated with audits and regulatory inspections
• Providing of input to process improvement.
• Escalation of issues to line managers on studies and timelines, as well as performance of CRA’s and CSC’s
• Collaboration with all relevant internal teams
• Bachelor’s degree in related discipline
• A Minimum of 3 years of experience in the capacity of Trial Manager or Senior CRA, working on Oncology studies is Non-Negotiable.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to plan, budget and quality.
• Excellent project management, team building and interpersonal skills.
• Excellent attention to details.
• Strong negotiation skills.