高级中央监控员
Senior Central Monitor
职位名称：高级中央监控员（远程）
工作地点：美国
工作地点类型：远程
工作合同类型：全职
职位级别：高级
ProPharma 过去25年来通过提供咨询和专业知识，帮助患者改善健康和福祉，使生物技术、医疗设备和制药组织能够自信地推进科学突破并引入新疗法。ProPharma 通过建议-建设-运营模式与客户合作，贯穿整个产品生命周期。凭借在监管科学、临床研究解决方案、质量与合规、药物警戒、医学信息和研发技术方面的深厚专业能力，ProPharma 提供端到端的完全可定制的咨询服务，降低风险并加速合作伙伴最重要的药物和设备项目。
中央监控助理职位负责在遵循标准操作规程（SOP）、监管要求、ICH 和 GCP 指南及研究特定计划的前提下，利用集中数据和报告工具为临床监控团队提供支持。
主要职责：
· 根据 FDA 或当地法规和指南、ICH GCP 和 ProPharma Group SOP 及项目计划，执行分配项目的远程站点监控和管理活动。
· 支持研究监控团队实施研究策略、倡议和流程及标准，确保一致、高效和高质量的流程，在预期时间内满足质量和研究交付要求。
· 支持数据收集和报告生成，以支持招募计划、入组情况、药物供应状态、站点付款状态及其他相关跟踪，以确保临床试验顺利执行。
· 支持按分配进行数据风险评估。
· 在研究期间支持监控团队，包括根据需要与临床机构沟通。
· 可能需要支持任何文件收集、访问准备、研究数据审查和中央监控活动，按分配的任务执行。
· 其他分配的职责。
必要技能和能力：
· 有效的沟通能力和人际交往能力，能够与跨职能的内部和外部利益相关者合作。
· 能够优先处理多项任务，主动规划，并按照明确的指示完成目标。
查看英文原文
Job Title: Senior Central Monitor (Remote)
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Central Monitoring Associate position is responsible for providing support to the clinical monitoring teams while utilizing centralized data and reporting tools in accordance with Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines and study specific plans.
Essential Functions:
· Performs remote site monitoring and management activities for assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and ProPharma Group SOPs and project plans.
· Supports study monitoring team in implementing study strategies, initiatives, and processes and standards, to ensure consistent, efficient, and quality processes to meet quality, and study delivery within the expected timelines.
· Supports collection of data, and report generation to support activities such as recruitment plan, and enrollment, drug supply status, site payment status, and any other relevant tracking to support successful clinical trial execution.
· Supports data risk assessments as assigned.
· Supports monitoring teams throughout the duration of the study including communication with the clinical site institutions as appropriate.
· May be required to support any document collection, visit preparation, and study data review and central monitoring activities as assigned.
· Other duties as assigned.
Necessary Skills and Abilities:
· Effective communication, and interpersonal skills with ability to partner with cross functional internal and external stakeholders.
· Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
· Ability to contribute to the development of tools and processes that increase measured efficiencies of the project.
· Proficiency in working with systems used in the clinical trial execution such as but not limited to Electronic Document Management Systems, Electronic Data Capture Systems, Clinical Trial Management Systems, etc.
· Exhibits a good understanding of general quality assurance concepts and practices.
· Highly organized with a strong attention to detail.
Educational Requirements:
· Bachelor’s degree preferred. Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.
Experience Requirements:
· Minimum 3 years of experience in study coordination and in house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or relevant, regulated environment.
Experience Desired:
- Working knowledge of Cluepoints RBQM System
- Long-haul COVID/Pulmonary experience
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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Originally posted on Himalayas