Lead CRA at ICON plc

Kuala Lumpur, Kuala Lumpur, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

0.0

Posted On

15 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Data Integrity, Compliance, Risk Mitigation, Site Performance, Monitoring Activities, Protocol Deviations, Recruitment Targets, Training, Mentoring, Audit Readiness, Collaboration, Decision-Making, Continuous Improvement, Health Authority Inspections, Project Management

Industry

Biotechnology Research

Description

Lead CRA ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. Review and assessing site performance, including enrollment, data quality, and compliance Identify risks and implement risk mitigation plans in collaboration with Clinical Operations Serve as functional lead for assigned CRAs, including but not limited to: Oversight of monitoring activities Review of monitoring visit reports according to review strategy Guidance on complex site issues and protocol deviations Oversee site metrics and site challenges Act as primary point of contact for any study monitoring related questions or concerns Motivate investigators to achieve recruitment targets and implement initiatives to improve recruitment Act as primary CRA for minimum 1 site to ensure they are familiar with the study/monitoring procedures May host regular calls with CRAs to discuss site level KPIs as needed Support onboarding, training, and mentoring of CRAs Keep the Project Manager regularly informed Partner with Clinical Project Managers, Medical Monitors, Data Management, Regulatory Affairs, and other stakeholders Provide input into study timelines, monitoring activities and site/study level challenges Participate in study team meetings and contribute to decision‑making Ensure audit and inspection readiness at all times Support internal audits, health authority inspections, and CAPA development Oversight of handovers of sites between CRAs post allocation of CRAs Promote a culture of quality, compliance, and continuous improvement Participate in training and mentoring CRAs as appropriate Conduct co-monitoring visits as needed to oversee the competencies and skills of the CRA Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by project manager. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

The Lead CRA will oversee and manage clinical trial activities, ensuring compliance with protocols and regulatory requirements. They will also act as a primary contact for study monitoring and support the training and mentoring of CRAs.