临床研究专员I - 客户专属 - 荷兰 - 远程办公
Clinical Research Associate I - Sponsor dedicated - Netherlands - Home based (m/
IQVIA™ 是领先的医疗健康数据科学公司,专注于帮助医疗客户发现无与伦比的洞察力和更好的患者解决方案。
由 IMS Health 和 Quintiles 合并而成,IQVIA 提供一系列解决方案,利用医疗数据的力量、专业领域知识、变革性技术和高级分析来推动医疗进步。
在我们针对客户的专属模式中,我们的团队为特定客户开发项目,因此我们的 CRA 是“适应症和分子专家”。我们通过启动阶段和临床研究期间的协作和面对面交流脱颖而出。
管理层认可我们临床团队的技能、才能和经验,并致力于在职能不断发展和壮大的过程中进一步提升这些优势。我们的经理了解客户的优先事项以及每个模式的个体特点。从第一天起就关注职业发展,包括新员工入职和培训、日常问题解决以及培训和发展。
此外,IQVIA 的客户专属业务遵循客户的 SOP,为双方提供更多的连续性。
我们的模式为有经验的 CRA 提供了扩展知识和技能的绝佳机会。
IQVIA 荷兰目前正寻找积极进取的临床研究助理 I 从业者加入我们独特且充满活力的客户专属模式。
该职位位于荷兰
您的职责:
- 根据合同范围和法规要求(即良好临床实践 GCP 和国际人用药品注册技术协调会议 ICH 指南)执行现场监查访问(选择、启动、监查和结清访问)
- 与现场合作,调整、推动并跟踪受试者招募计划,以符合项目需求,提高可预测性
- 向指定现场提供方案及相关研究培训,并建立与现场的定期沟通渠道,以管理持续的项目期望和问题
- 评估与方案正确实施和适用法规遵守相关的现场研究质量与完整性。适时升级质量问题
- 通过跟踪监管提交和批准、招募和入组、病例报告表(CRF)完成和提交,以及数据疑问生成和解决来管理所负责研究的进展。可能支持启动阶段
查看英文原文
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Within our Sponsor dedicated model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.
Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.
Additionally, IQVIA’s sponsor dedicated business works with the Sponsors SOP’s, creating more continuity for both parties.
Our models offer excellent opportunities for experienced CRA’s to expand their knowledge and skills.
IQVIA Netherlands are currently seeking motivated Clinical Research Associate I practitioner to join our unique and dynamic Sponsor dedicated model.
This is a role based in the Netherlands
Your Role:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
Your Profile:
- Bachelor's Degree Degree in scientific discipline or health care
- Minimum of 6 months of independent, on-site monitoring experience within a CRO or pharmaceutical environment.
- Full professional fluency in both Dutch (minimum C1 level) and English, including strong medical writing skills for reports.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Organizational and problem-solving skills.
- Exceptional interpersonal and cross-cultural communication skills to build strong, trusted partnerships with Dutch site investigators and medical staff.
- A collaborative mindset to work effectively with cross-functional global teams, project managers, and local study coordinators.
What we offer:
- Choice of a company car (eligible for private use) or a flexible mobility allowance, fully covering fuel, insurance, and maintenance.
- Premium technology bundle to support your daily operations, including a laptop and an iPhone.
- Strong focus on career advancement, featuring dedicated training programs, learning resources, and pathways to build clinical or leadership expertise.
- Home office setup support, alongside an annual wellness reimbursement to fund your sports and wellbeing activities.
- Comprehensive time-off policy, including competitive annual vacation days and flexible year-end leave options.
- Premium benefits package featuring a robust pension plan, multiple corporate insurance coverages, and social activities.
- Optional partial reimbursement for supplementary health insurance policies to support your healthcare needs.
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