Clinical Trial Manager II, Dermatology & Rheumatology CRO, USA
临床试验经理 II 负责临床试点的运营管理和监督，以及临床试题临床监测成果。包括但不限于临床研究员 (CRA) 的培训，识别与现场性能和临床监控活动有关的质量问题，制定应对任何关切的行动计划，并确保时间表得到满足。· 如果你喜欢与中型 CRO 合作，你可以在所有层面上建立专业关系。·你带来了在管理临床监测部分的经验；·皮肤学是一个治疗领域，你喜欢或想了解更多有关责任。·确保临床监控活动以赞助商的满意度进行，并确保及时质量交付，并且符合适用的标准操作程序 (SOP),法规，良好的临床实践和研究特定要求；·通过项目会议，网站通信，现场访问报告和后续信件，质量控制访谈和质量保证审计调查结果确定与现场绩效和临床监测活动有关的质量问题和趋势。总结发现并制定行动计划来采取纠正措施；· 作为 CRA 和首席 CRA 的接触点；· 为 CRA 和主要 CRA 提供指导/监督；· 对分配项目的现场访问的报告进行审查，并追踪现场访问报表标准以确保遵守情况；· 在临床监控计划的开发中贡献；·为 CRA 准备和开展项目具体培训；·制定注释的现场访问报告和监测工具，如源数据验证工作表；·与 CRA 进行质量控制访问；·协调并领导 CRA 会议；·与 CRA 进行联合监督访问；·可能参与业务发展活动 （客户会议，提案辩护会议，提出建议请求）信息要求 (RFIs). · 经验至少8年，包括以前的监测经验和在 L1中工作经验至少2年的经验。
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Description
The Clinical Trial Manager II is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables of clinical trials. This includes but is not limited to clinical research associate (CRA) training, identification of quality issues related to site performance and clinical monitoring activities, establishing action plans to address any concerns, as well as ensuring timelines are met.
This role will be perfect for you if:
- You enjoy working with a mid-sized CRO where you can build professional relationships with your colleagues at all levels
- You bring previous experience in managing the clinical monitoring portion of clinical projects
- Dermatology is a therapeutic area you enjoy or want to learn more about
RESPONSIBILITIES
- Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
- Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
- Serves as a point of contact for CRAs and Lead CRAs for assigned projects;
- Provides mentoring/oversight of CRAs and Lead CRAs;
- Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance;
- Contributes to the development of the Clinical Monitoring Plan;
- Prepares and conducts project-specific training for the CRAs;
- Develops the annotated site visit reports and monitoring tools such as source data verification worksheets;
- Conducts quality control visits with CRAs;
- Coordinates and leads CRA meetings;
- Performs co-monitoring visits with CRAs;
- May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).
Requirements
IDEAL PROFILE
Education
· B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience;
Experience
· At least 8 years of clinical research experience including prior monitoring experience and at least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;
Knowledge and skills
- Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
- Excellent mastery of Microsoft Office suite (Word, Excel, Power Point);
- Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites and sponsors;
- Excellent leadership, organizational, time management and multi-tasking skills;
- Excellent judgement and problem-solving skills;
- Occasional travel (up to 10% of the time), including some travel outside of the country once possible;
- Fluent in English (excellent oral and written);
- Experience in a CRO and in dermatology an asset.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Flexible work schedule / work schedule :
- Home-based position
- Benefits
- Ongoing learning and development
About Indero
Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in the US .
Originally posted on Himalayas