Global Studies Leader (GSL)

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

As the Study Management Team Lead, your key responsibilities include:

● Lead and coordinate a cross-functional study team of experts , in compliance with ICH-GCP

and Roche processes in accordance SOPs and guidelines to ensure the clinical study

progresses as planned through driving the achievement of milestones according to

timelines, budget and quality standards

● Provide input into and hold accountability for the development of essential study level

documents (i.e. Clinical Study Protocol, Clinical Study Report) in accordance with relevant

SOPs

● Develop and maintain in collaboration with CRO partners quality risk strategy, relevant

study plans and data to drive clinical study execution and allow adequate oversight

● Accountable and responsible to ensure data entry timeliness and accuracy in our systems,

regardless of who is accountable or responsible for entry of the data

● Lead/facilitate communication across all functions and provide guidance and support to

the core and extended study team members as needed

● Drive innovation in clinical operations by thinking of and contributing to the

implementation of new approaches in partnership with COE, APO and HBS in order to

deliver outcomes that meet and exceed industry best practices.

● Build and role model effective study partnership behaviors and mindsets with your TA

aligned CRO partner to ensure we maximize the expertise of the CRO and our internal

colleagues, minimising duplication of work and ensuring cost and resource efficiency for

study(ies) in responsibility

● Ensure all external service providers (ie, CROs, IXRS, ePRO, etc.) that are engaged at the

study level are delivering to their contractual obligations within the agreed timelines and

budget, and that oversight is documented and issues escalated as appropriate.

● Oversee study level performance against agreed upon plans, milestones and key

performance indicators (KPIs, quality and operational) by using company tracking systems

and proactively communicating any risks to timelines and/or quality, or identified quality

issues, along with proposed mitigations to your Operations Asset Leader and your People

leader

● Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, ensuring QC

activities are performed on an ongoing basis to maintain TMF completeness at all times

● Ensure timely compliance with company-wide governance controls (e.g. Delegation of

Authority, Sunshine Act)

● Develop and oversee the study budget throughout the study lifecycle including budget

re-forecasting, identification of any financial risks and enactment of mitigation plans.

Including proactive communication of financial risk and mitigation plans to the GOAL

● Maintain study inspection readiness at all times, according to ICH-GCP and relevant SOPs,

policies/guidelines and support for asset filings; the GSL is the primary Study

point-of-contact in the event of a study audit or inspection

● Provide study team members and their line managers with regular feedback on their

individual performance to support their professional development and the achievement of

a High Performing Organization

● Work on non-asset project work, such as the Subject Matter Experts (SME) representative

in change initiatives that drive process improvements and/or lead improvement projects as

discussed and agreed upon with their manager

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。