Lead CRA

What You Will Be Doing

• Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines.
• Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance.
• Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations.
• Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies.
• Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.

Your Profile

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.
• Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
• Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
• Experience in Gene Therapy or Ophthalmology studies (complex indications).

Benefits

• 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 who are there to support you and your family's well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.