研究运营经理/临床试验经理 - FSP
Study Operations Manager/Clinical Trial Manager - FSP
当我们的价值观一致时，我们能够实现无限可能。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每项临床开发解决方案都建立在一个特别的基础之上——对所做工作的深刻信念。
无论我们在Parexel做什么，每个人都在为最终能惠及患者的疗法开发做出贡献。我们认真对待工作，以同理心去完成，并致力于带来改变。
研究运营经理负责一项或多项研究的从研究启动到执行及收尾的地区或特定国家层面的活动，提供领导力、战略规划和组织能力，以确保任务的运营管理。
- 作为一项或多项研究的本地研究团队负责人
- 在需要时为GSM提供支持或承担其职责
- 根据整体项目计划，监督指定研究的首选合同研究组织和/或国家试验经理/站点护理合作伙伴，并管理并维护准确的国家层面计划（例如，时间表、预算、风险和质量计划）
- 可能负责指定国家的研究启动流程，并根据情况监督负责这些活动的CRO
- 与SCP、首席SCP、站点激活合作伙伴和当地监管同事联系，就向卫生当局（HAs）和伦理委员会（ECs）提交策略达成一致
- 在规划期间提供国家层面的启动和招募里程碑输入
- 与相关角色合作，识别和管理研究启动和执行中的偏差和风险，并根据需要实施缓解策略
- 对站点激活升级至研究团队的解决负责，包括提供缓解方案
- 对以下事项负全责并承担责任，由GSM指定：
- 地区、国家和研究层面的启动和站点激活计划的实施
- 地区、国家和研究层面的招募策略
- 研究层面计划的制定
- 与本地团队和内部利益相关者以及CRO（如适用）沟通，以确保按计划高效及时地开展研究
- 研究和/或国家供应商管理和监督，包括跟进和协调供应商交付物
- 确保符合要求
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Study Operations Manager has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.
- Serves as leader of the local study team on one or more studies
- Provides back up to or assumes the responsibilities of the GSM as needed
- Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
- May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable
- Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
- Provides country level input on startup and recruitment milestones during planning
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
- Accountable for resolution of site activation escalations to study teams including offering options for mitigation
- Fully responsible and accountable for, as designated by the GSM:
- Regional, country, and study level implementation of startup and site activation plans
- Regional, country and study level recruitment strategy
- Development of study level plans
- Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans
- Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
- Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.
Requirements:
- Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
- Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
- A scientific or technical degree is preferred
Originally posted on Himalayas