站点启动总监
Director, Site Start Up
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开展工作，从而实现精准医学的科学目标。
由于持续增长，我们正在寻找一位 Site Start Up 部门总监
职位简介：为 Site Start-up（SSU）部门提供领导力。在人员、流程和系统方面，为 SSU 部门的实施和扩展战略及方向做出贡献。与其他职能团队协作，确保 SSU 交付和客户满意度（通常包括知情同意书审查与修改、监管文件收集与质量审查、对监管和机构在 IRB/EC/CA 提交方面的支持，以及对机构合同组在预算和合同谈判方面的支持）。与 Site Start Up 主管密切合作，持续发展 SSU。确保临床试验的执行和交付符合监管要求（本地和区域）、ICH 指南、良好临床实践（ICH）和标准操作程序（SOP）。
该职位的核心职责包括但不限于：
• 为 SSU 团队提供与 SSU 项目交付、沟通、人力资源、收入提升、流程、系统和程序相关的指导、领导和支持，以满足客户和部门目标。
• 直接管理或跨职能监督涉及不同领域站点启动的部门（如本地/中央 IRB/伦理委员会（EC）提交、主管当局（CA）提交、其他相关监管机构/组织、站点合同和预算谈判以及其他启动需求），以支持站点启动的整体管理。
• 与 Site Start Up 主管紧密合作，建立 Precision for Medicine（PFM）SSU 框架，以确保项目执行和交付，包括 SSU 智能化、工具和方法、风险评估和缓解措施。
• 支持 SSU 与临床运营团队、项目管理和其他相关跨职能部门在全球和/或区域范围内进行 SSU 活动的规划、执行和治理。
• 与 Site Start Up 主管合作，制定和优化 SSU 的整体策略和流程。
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.
Due to our continued growth we are seeking a Director, Site Start Up
Position Summary: Provides leadership to the Site Start-up (SSU) department. Contributes to the strategy and direction of the implementation and expansion of the SSU department in terms of people, processes and systems. Collaborates with other functions to secure SSU delivery and client satisfaction on SSU activities (typically, these include activities such as Informed Consent Form review and adaptation, Regulatory Document collection and quality review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group in budget and contract negotiation). Works closely with the Head of Site Start Up on the ongoing development of SSU . Ensures the conduct and delivery of clinical trials in compliance with Regulatory requirements (local and regional), ICH Guidelines, Good Clinical Practices (ICH) and SOPs.
Essential functions of the job include but are not limited to:
• Provides SSU team with guidance, leadership and overall support relating to SSU project delivery, communication, human resources, revenue enhancement, procedures, systems and processes to meet client and departmental targets.
• Supports the overall management of site start up delivery either by direct management and/or cross functional oversight of the depts involved in the different areas of site start-up (Local/Central IRB/Ethics Committee (EC) submissions, Competent Authorities (CA) submissions, other related governing organizations/bodies, site contracts and budget negotiations and any other start up requirements).
• Works closely with the Head of Site Start Up to establish the Precision for Medicine (PFM) SSU framework to ensure project execution and delivery including SSU intelligence, tools and methodology, risk evaluations and mitigations.
• Supports SSU collaboration with Clinical Operations team, project management and other relevant cross functional departments in the planning, execution and governance of SSU activities globally and/or regionally
• Works with the Head of Site Start Up to support defined corporate and departmental business strategies for PfM
• Acts as an ambassador for change management for evolution of global structure for PFM growth and expansion
• Provide leadership and oversight on SSU programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design)
• Manage escalations and remediation of SSU concerns timely and effectively
• Supports optimization of processes and delivery with the goal of contributing to the profitability of the SSU teams to meet or exceed budget targets
• Partner with Global Resourcing teams for assessment and management of team members (SSU leads, SSU Specialist and Site Contract Management staff) to ensure that established cost, time, and quality goals are met
• Supports SSU team career development, growth and succession planning activities. Ensures compliance with company policies and procedures and other applicable regulatory guidelines
• Supports coordination of SSU Lead’s participation in current and prospective client meetings and presentations to ensure PfM customer service is well represented
• Collaborates with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance for any SSU participants
• Works with global/regional functional leaders to support SSU project strategy and SSU delivery
• Supports SSU evaluations and implements required changes for all projects
• Develop, measure and report SSU KPIs and lead continuous improvement
• Recognize, exemplify, and adhere to PFM’s values that center on our commitment to quality, our people, clients and performance
• Leverage communication skills and experience to reinforce PfM culture and values to motivate, maintain engagement and drive retention for SSU team
Requirement :
• Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience.
• A minimum of 12 years in clinical research including extensive experience of Site Start-up
• Extensive leadership experience or proven competencies for this position.
• Expert knowledge of GCP/ICH guidelines and the clinical development process.
Other Required:
• Demonstrated leadership track record
• Experience working in team environment with resource management experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Proven experience in strategic planning, risk management and change management
• Fluency in English.
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