Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Clinical Research Manager based in United States. This role oversees clinical monitoring activities and supports the performance and development of a team of Clinical Research Associates (CRAs). You will help ensure clinical trials are conducted with high quality and in compliance with ICH-GCP, applicable regulations, and standard operating procedures. The position combines people leadership, resource planning, quality oversight, and clinical trial execution. You will work closely with cross-functional teams and clinical sites to support study milestones and address operational risks. The role also provides opportunities to strengthen monitoring capabilities, improve processes, and contribute to audit and inspection readiness. It is well suited to an experienced clinical research professional who enjoys developing people while maintaining strong standards for trial delivery. Accountabilities: - Allocate CRA resources and conduct ongoing workload assessments to maintain balanced assignments, support quality monitoring, and meet study deliverables. - Assess and strengthen CRA knowledge and monitoring capabilities, ensuring team members have the skills and support required to perform their responsibilities effectively. - Monitor CRA performance and quality indicators and address issues in accordance with ICH-GCP, applicable regulations, and internal procedures. - Build strong relationships with clinical sites to support performance, study execution, and consistent trial delivery. - Review monitoring quality, identify compliance issues, and implement appropriate resolution strategies in collaboration with relevant stakeholders. - Support study and site milestone delivery through effective collaboration with cross-functional teams. - Conduct or support assessment and accompanied visits when required to evaluate CRA monitoring competency and identify development or performance needs.

- Contribute to process optimization initiatives and appropriately escalate and resolve clinical trial risks and operational issues. - Support site audits, inspections, and Site Compliance Visits, including corrective action planning and follow-up on identified findings. - Recruit, onboard, assign responsibilities to, and provide ongoing support and resources to team members. - Conduct regular performance evaluations, provide constructive feedback, and address personnel matters promptly and fairly. - Mentor team members and support their professional development by identifying appropriate learning and career-development opportunities. - Foster open communication, collaboration, accountability, and a positive team culture within the CRA team and across functions. - Serve as a point of contact for issue escalation, feedback, and coordination with other stakeholders when needed. Requirements: - Bachelor’s degree or higher in a scientific or healthcare discipline is required; an advanced degree is preferred. - At least 5 years of industry experience in the pharmaceutical, CRO, or a related clinical research environment. - Thorough understanding of the drug development process, including strong knowledge of ICH-GCP, international standards, health authority requirements, and clinical trial compliance. - Comprehensive understanding of clinical monitoring and trial execution, with previous experience working as a CRA preferred. - Experience in oncology is highly recommended. - Demonstrated ability to lead, mentor, develop, and evaluate team members while managing workload, performance, and professional development. - Strong organizational, interpersonal, analytical, and problem-solving skills, with the ability to manage competing priorities and maintain high-quality standards.

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