Local Clinical Study Manager (Belgium/ Denmark/ Netherlands/ Sweden)
专注于 IQVIA 赞助商的临床功能服务伙伴关系 (Clinical FSP) 部门正在支持我们的客户项目团队执行临床试验。加入该团队提供了管理不同治疗领域的临床研究项目和与我们关键客户之一密切合作的机会。目前,我们为你提供了一个令人兴奋的机会,以全职和家庭环境作为本地临床研究经理加入团队。这个位置可以位于比利时或丹麦,荷兰或瑞典。在此职位上,你将负责对经营和科学监督,在本地层面设置,执行和执行分配给你的临床试验。主要责任 · 提供全面的临床研究领导和监督试验交付,执行,质量,时间表和结果。· 领导并管理跨功能临床团队,确定优先事项,期望以及确保有效沟通。·计划和监督日常研究监测活动,提供状态更新和推动研究进展。· 管理供应商和预算 (如适用)并协调资源支持研究目标。· 推动现场激活和启动活动,与监管部门,初创公司和内部团队合作。· 监督研究质量和合规性,识别风险,实施减缓计划并主动解决问题。· 审查和批准监测报告,确保及时的随访和解决相关发现。· 开发和提供特定研究培训,支持临床人员和 CRA 持续发展。·分析研究指标和趋势,利用数据来提高执行,一致性和质量在各国和地区之间。· 确保监管合规,包括提交,批准,更新,报告要求以及遵守 ICH-GCP 和当地法规。· 监督试验主文件 (eTMF) 的质量,确保基本文档完整并符合。· 对审计,CAPA 活动和检查准备性的质量保证 (QA) 合作伙伴。·作为临床监测问题的首要接触点,协调利益相关者和供应商之间的沟通。· 促进跨职能团队之间积极解决问题和升级管理。· 维护项目计划,工具,系统和报告以确保精确的项目跟踪和可见性。需要的技能和质量
查看英文原文
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as a Local Clinical Study Manager in full-time and home-based setting. The position can be located in Belgium or Denmark or Netherlands or Sweden. In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of your assigned clinical trials at the local level.
MAIN RESPONSIBILITIES
- Provides overall clinical study leadership and oversight for trial delivery, execution, quality, timelines, and outcomes.
- Leads and manages cross-functional clinical teams, setting priorities, expectations, and ensuring effective communication.
- Plans and oversees daily study monitoring activities, providing status updates and driving study progress.
- Manages vendors and budgets (when applicable) and coordinates resources to support study objectives.
- Drives site activation and startup activities, collaborating with regulatory, startup, and in-house teams.
- Monitors study quality and compliance, identifying risks, implementing mitigation plans, and addressing issues proactively.
- Reviews and approves monitoring reports, ensuring timely follow-up and resolution of site-related findings.
- Develops and delivers study-specific training and supports ongoing development of clinical staff and CRAs.
- Analyzes study metrics and trends, using data to improve execution, consistency, and quality across countries and regions.
- Ensures regulatory compliance, including submissions, approvals, renewals, reporting requirements, and adherence to ICH-GCP and local regulations.
- Oversees Trial Master File (eTMF) quality, ensuring essential documents are complete and compliant.
- Partners with Quality Assurance (QA) on audits, CAPA activities, and inspection readiness.
- Acts as the primary point of contact for clinical monitoring issues, coordinating communication across stakeholders and vendors.
- Facilitates proactive problem-solving and escalation management across cross-functional teams.
- Maintains project plans, tools, systems, and reporting to ensure accurate project tracking and visibility.
REQUIRED SKILLS AND QUALIFICATIONS
- Bachelor degree in related discipline, preferably in life science
- Five or more years of experience in clinical research, including a minimum of 2 years' project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
- Previous work experience in TA's: Oncology or Onco-hematology is required
- Good knowledge of the Drug Development Process
- Excellent knowledge of spoken and written English and local language.
- Good ability to learn and to adapt to work with IT systems.
- Effective decision-making is crucial for resolving challenges and ensuring alignment with overall study goals.
- Experience in monitoring study activities for compliance and inspection readiness.
- Strong interpersonal skills are vital for collaborating with internal teams, stakeholders, and external vendors.
- A deep understanding of clinical operations processes, including trial data collection and management, is paramount to ensuring successful study execution.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
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 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.
Originally posted on Himalayas