Site Activation Manager
职位标题:网站激活经理工作地点:虚拟澳大利亚工作地址类型:远程工作合同类型:全日制工作资深级别:我们是谁 我们是一个全球中大型的 CRO,超越界限,创新和发明,因为世界上最持久的疾病的治疗路由不由那些玩得安全的人铺平。它是由那些采取先,创造性方法并以质量和卓越的方式实施者构建的。我们是世界范围内的临床试验,我们是一支拥有超过3,500+专家,聪明思想家,梦想家和行为者的全球团队,共同改变了世界 CROs 的体验方式。我们的使命是每天以热情和目的努力改善生活,我们正在寻找那些重视同样的追求的人。为什么全球 我们相信每个人都在为患者及其护理人员带来变化方面发挥重要作用。从我们的实践可靠领导者到我们的团队,我们致力于让来自不同背景和经验的专业人士取得成功。我们优先培养多元化的包容环境,继续促进合作和创造力。我们自豪地成为一个通过自我发展而成长并受到鼓舞的工作场所。加入我们!*摘要:负责在分配的治疗领域内的现场激活项目管理和交付活动。责任包括协调,协作和监督现场识别和中央和国际委员会 (仅适用于国家 NA)的活动,对必要文件收集的进展,调查人员和现场合约状况的监测以及根据良好临床实践 (GCP) 和适用的当地和国际法规和标准操作程序 (SOP) 要求进行现场激动所其他任何国家和/或研究特定现场激励任务。应对任务可能包括但不限于:_服务作为主要的沟通点和负责研究启动和维护活动 (如有)在分配项目上。监督参与网站激活的功能组项目的项目活动,以确保关键途径的活动得到实现。
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Job Title: Site Activation Manager
Job Location: Virtual Australia
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
*SUMMARY: Accountable for site activation project management and delivery activities within the assigned therapeutic area. Responsibilities include coordination, collaboration and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre award support by providing site activation related input into the proposal text and budget items. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area.RESPONSIBILITIES:*_Tasks may include but are not limited to: _Serve as the primary point of communication and accountability for study start-up and maintenance (if applicable) activities on assigned projectsOversee project activities of functional groups involved in site activation to ensure critical path activities are completed on-time and within budgetEnsure accurate compilation, management, tracking and analysis of site activation activities in a timely mannerMay support feasibility and/or site identification activities, as neededWork closely with assigned team members to expedite the Site Qualification and Selection processEffectively communicate Site Activation & Regulatory (if applicable) project status to the Sponsor, GPL/CPM and project teamPrepare risk assessment and mitigation plans relating to project deliverables with input from other rolesResponsible that relevant study activities are present in the work order budget. Ensure OOS activities are tracked and captured within Change Notification Form (CNF) and follow through to execution of change orderWork in conjunction with assigned project team members to develop and maintain site activation related project plansMay contribute to the development, review, and maintenance of SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation departmentProvide input to departmental process improvement initiativesEstablish and interpret site activation metrics to help drive corrective action for achieving deliverables, milestones and/or KPIsMay participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals, budgets and other country and/or study specific activities related to Site ActivationReport and/or escalate issues to Line Manager, Site Activation Portfolio Lead and/or Site Activation Therapeutic Lead to ensure resolution and minimize risks to on-time deliverablesComply with SOPs, ICH GCP and national regulations as applicableLiaise with other functional contributors and vendors as neededPerform other duties as assigned The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.*OTHER SKILLS AND ABILITIES: *Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquingAbility to exercise sound judgment and make decisions independently and to proactively identify and solve problemsAbility to provide experience and input into initiatives relating to interacting with sites and/or customersAbility to motivate, lead and engage a teamStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentStrong oral and written communication skills to clearly and concisely present informationDemonstrated ability to collaborate across the businessTeam-oriented work style; seeks and gives guidanceUnderstanding of regulatory processes and guidelinesUnderstanding of initiation, planning, and execution of clinical projects and overall project planningAwareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)Ability to handle multiple tasks in a fast-paced and constantly changing environmentAbility to work in an organized, methodical, and self-motivated mannerProficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude*REQUIREMENTS: *A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs)Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experienceProficient in cross-cultural communicationProficient in both spoken and written EnglishPromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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Originally posted on Himalayas