初创企业负责人 APAC
Start Up Lead APAC
Precision for Medicine 是一家临床研究组织。Precision 独特的整合服务通过结合创新的临床试验设计、行业领先的运营和医学专家、先进的生物标志物和数据分析解决方案，以及对罕见病和肿瘤学的坚定热情，同时在其他治疗领域也开展工作，从而实现了精准医学的科学性。
随着公司持续发展，我们正在寻找一位亚太区站点启动负责人加入我们的团队。地点：澳大利亚/新加坡/韩国/台湾/中国。
职位概述：
启动（SU）负责人是全球站点启动活动的专家，负责执行站点启动策略和计划，包括核心/站点文件收集和批准、知情同意书（ICF）定制和批准、IRB/EC 和 CA/ MoH 提交以及质量合格的 IMP（试验药物）释放包的交付。将作为站点启动活动的问题专家，为其他国家成员（SUSs、CRAs、CSSs 或其他人员）提供支持，对经验较少的员工进行站点启动活动培训，并可能被指定为国家特定工具和指导文件的所有者，以提高国家特定站点启动活动的知识共享。
该职位的主要职责包括但不限于：
• 通过制定激活准备策略来管理站点启动流程，以实现对站点启动交付的监督。
• 协调、开发并展示关键路径计划，包括 IRB/EC 和 CA/ MoH 策略、ICF 定制、风险缓解、IMP 释放要求和合同执行。
• 与相关方协作和沟通，获取里程碑计划的输入，并确保操作目标的一致性，以确保站点启动活动按时完成，实现及时激活。
• 参与客户会议，建立客户对交付、沟通、风险缓解策略、状态报告和与站点启动相关的指标的期望。
• 与职能负责人和站点启动专家紧密合作，主动识别任何影响交付的风险，并制定和执行缓解措施以消除对时间线的风险。
• 监督确保已商定的跟踪系统和数据的准确性与完整性，并实时维护，以便在研究、国家和站点层面分析进度指标与目标/时间表的对比。
• 负责共同…
查看英文原文
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.
Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.
Essential functions of the job include but are not limited to:
• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
Qualifications:
Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.
Other Required:
• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
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