Clinical Trial Manager (Sponsor Dedicated)
职位标题:临床试验经理 (赞助商专注)工作地点:美国北卡罗来纳州德哈姆市。工作地点类型:远程工作合同类型:全日制工作资深级别:本地试验经纪人 (LTM) 全球临床运营概况 本地试验管理者 (LTM),在分配国家内提供了临床试管的当地管理,确保研究按照协议要求,适用法规,ICH-GCP 指导方针和内部程序进行。负责监督从启动到关闭的运营研究交付,同时与跨职业利益相关者合作以确保质量,时间表和患者招聘目标得到实现。主要责任 ·领导国家级执行分配临床试验,确保里程碑,质量指标和时间表达到。·作为特定国家的研究操作的主要接触点。·支持站点识别,可行性评估,站点选择和激活活动。·与调查人员,站点工作人员以及跨职能团队合作推动研究绩效和注册。· 监督研究进展,主动确定和减轻运营风险。·确保遵守适用的监管要求,GCP 指南,学习协议和 SOP. · 在整个研究生命周期中监督现场准备性,现场性能和问题解决方案。· 与研究团队合作开发和执行招聘和保留策略。· 促进研究团队会议并沟通研究更新,风险和减缓计划。· 支持供应商的管理,研究用品,预算以及发票活动如有所需。·与研究初创团队合作协调当地监管提交和批准。· 确保及时和准确地维护研究文档,CTMS 和 eTMF 记录。·支持审计和检查准备性活动并通过纠正行动帮助解决发现的情况。· 确保有关安全信息和协议偏差的适当报告和文件。· 促进整个组织中改善进程倡议和最佳实践分享。资格 · 获得生命科学,医疗保健,护理,药业或相关领域学士学位;· 临床研究经验与管理临床试验活动的证明经验。· 有强大的知识 ICH-GCP,临床试题监管。
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Job Title: Clinical Trial Manager (Sponsor Dedicated)
Job Location: Durham, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Local Trial Manager (LTM)
Global Clinical Operations
OverviewThe Local Trial Manager (LTM) provides local management of clinical trials within assigned countries, ensuring studies are conducted in accordance with protocol requirements, applicable regulations, ICH-GCP guidelines, and internal procedures. The LTM is responsible for overseeing operational study delivery from startup through closeout while partnering with cross-functional stakeholders to ensure quality, timelines, and patient recruitment objectives are achieved.
Key Responsibilities
· Lead country-level execution of assigned clinical trials, ensuring milestones, quality metrics, and timelines are met.
- Serve as the primary point of contact for country-specific study operations.
- Support site identification, feasibility assessments, site selection, and activation activities.
- Collaborate with investigators, site staff, and cross-functional teams to drive study performance and enrollment.
- Monitor study progress and proactively identify and mitigate operational risks.
- Ensure compliance with applicable regulatory requirements, GCP guidelines, study protocols, and SOPs.
- Oversee site readiness, site performance, and issue resolution throughout the study lifecycle.
- Partner with study teams to develop and execute recruitment and retention strategies.
- Facilitate study team meetings and communicate study updates, risks, and mitigation plans.
- Support management of vendors, study supplies, budgets, and invoicing activities as applicable.
- Coordinate local regulatory submissions and approvals in partnership with study startup teams.
- Ensure timely and accurate maintenance of study documentation, CTMS, and eTMF records.
- Support audit and inspection readiness activities and help address findings through corrective actions.
- Ensure appropriate reporting and documentation of safety-related information and protocol deviations.
- Contribute to process improvement initiatives and best practice sharing across the organization.
Qualifications
· Bachelor's degree in Life Sciences, Healthcare, Nursing, Pharmacy, or a related field preferred.
- Clinical research experience with demonstrated experience managing clinical trial activities.
- Strong knowledge of ICH-GCP, clinical trial regulations, and study conduct requirements.
- Experience working with investigators, clinical sites, and cross-functional study teams.
- Excellent organizational, communication, and stakeholder management skills.
- Ability to manage multiple priorities in a fast-paced, matrixed environment.
- Experience with CTMS, eTMF, and other clinical trial management systems preferred.
- Proficiency with Microsoft Office applications.
- Ability to travel as required.
Preferred Experience
· Experience overseeing studies from startup through closeout.
- Experience supporting global or multicountry clinical trials.
- Strong problem-solving skills with the ability to proactively identify and address study risks.
- Demonstrated ability to build effective relationships with internal and external stakeholders.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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Originally posted on Himalayas