Clinical Trial Manager II

About the Role

The Clinical Trial Manager II role is a site-aligned, end-to-end partner that streamlines communication across stakeholders, ensuring that all parties are informed and aligned throughout the trial. This role requires a deep understanding of site operational models and the ability to build strong relationships with critical site stakeholders.

What You Will Do

• Oversee the execution of clinical trials from start to finish, ensuring compliance with GCP guidelines, regulatory requirements, and ICON's SOPs
• Serve as the primary point of contact for sites, facilitating communication and issue resolution across cross-functional stakeholders
• Develop and maintain strong relationships with critical site stakeholders, including investigators and site staff
• Collaborate with central study teams and local stakeholders to select sites for participation in trials
• Ensure that local/country teams meet recruitment targets with high-quality data on time and within study budgets
• Provide input to study-level documents and lead/co-ordinate local team activities in compliance with SOPs, procedural documents, and applicable regulations
• Act as the primary company contact for assigned trial sites, engaging with investigators and site staff throughout the life of the trial
• Focus on investigator engagement through timely follow-up with sites and prompt communication of relevant status information and issues to stakeholders
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress
• Initiate corrective and preventive actions (CAPA) when the trial deviates from plans, communicating study progress and issues to study management teams and the Quality & Compliance team

What We Are Looking For

• Bachelor's degree in a life science or related field (e.g., biology, chemistry, nursing)
• At least 5 years of experience in clinical trial management, with a strong understanding of GCP guidelines and regulatory requirements
• Excellent communication and interpersonal skills, with the ability to build strong relationships with sites and stakeholders
• Strong organizational and project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously
• Experience with clinical trial management systems, including trial master files (TMFs) and electronic trial master files (eTMFs)
• Knowledge of ICH-GCP guidelines and regulatory requirements, including FDA and EU regulations
• Ability to work effectively in a remote setting, with strong self-motivation and discipline

Nice to Have

• Experience with electronic data capture (EDC) systems and clinical trial management software
• Knowledge of statistical analysis and data management principles
• Experience with quality assurance and quality control processes
• Certification in clinical trial management, such as CCRA or ACRP

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading healthcare intelligence and clinical research organization
• Collaborative and dynamic work environment
• Professional development and training opportunities
• Flexible work arrangements, including remote work options
• Access to cutting-edge technology and tools
• Recognition and reward programs for outstanding performance

• Tip: Highlight your experience with clinical trial management systems, including trial master files (TMFs) and electronic trial master files (eTMFs), to stand out as a strong candidate.
• Tip: Emphasize your ability to build strong relationships with sites and stakeholders, as this is a critical aspect of the Clinical Trial Manager II role.
• Tip: Be prepared to discuss your experience with quality assurance and quality control processes, as well as your knowledge of ICH-GCP guidelines and regulatory requirements.
• Tip: Showcase your ability to work effectively in a remote setting, with strong self-motivation and discipline, to demonstrate your fit for this role.
• Tip: Consider obtaining certification in clinical trial management, such as CCRA or ACRP, to enhance your credentials and competitiveness as a candidate.