China Biomaker Studies Asset Manager

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

YOUR TEAM

You will report to the HGR Officer and partner closely with the global biosample operations teams across the enterprise. You will be recognized as a leader and work autonomously in both local as well as global cross functional study teams.

ROLE PURPOSE

As a China Biosample Operations Asset Lead, you will provide biosample operational expertise to one or more cross-functional local or global study teams through all phases and stages in accordance with the appropriate quality standards and applicable local regulations.

WHAT YOU WILL DO

PROVIDE BIOSAMPLE OPERATIONS GUIDANCE TO CLINICAL CHINA STUDY TEAMS AND GLOBAL STUDY TEAMS FOR CHINA RELATED ACTIVITIES by planning, coordinating, and overseeing all operational activities required to manage the lifecycle of study samples (collection, processing, analysis, data delivery and final disposition).

LEAD THE DEVELOPMENT OF A CHINA SPECIFIC BIOMARKER MANAGEMENT PLAN WITHIN CLINICAL STUDIES based on input from scientific and operational stakeholders to execute biosample operational strategies in China

PROVIDE INPUT TO HGRAC APPLICATION to support Country Study Managers - when applicable - and within Biosample Operations’ remit.

PARTNER CLOSELY WITH BIOMARKER SCIENTISTS AND BIOSAMPLE OPERATIONS PROGRAM LEADS LOCALLY AND GLOBALLY to align study specific activities with program sample collection strategies. Evaluate the operational feasibility of specific testing in China and provide input to global program teams.

PROVIDE OPERATIONAL INPUT AND RECOMMENDATIONS INTO STUDY RELATED DOCUMENTATION AND PROCESSES (e.g. protocol, ICF, HGRAC applications)

PRESENT CHINA STUDY SAMPLE COLLECTION STRATEGY AT OPERATIONS TEAM MEETINGS AND CHINA INVESTIGATOR MEETINGS

CONTRIBUTE TO LOCAL LAB/ REGIONAL VENDOR SELECTION FOR SPECIFIC TESTING in collaboration with Biosample Ops Lead, biomarker scientist, Procurement and based on technology expertise, performance and compliance.

ESTABLISH BIOSAMPLE ANALYSIS AND DATA DELIVERY MILESTONES AND ENSURE ACCURATE TRACKING AND REPORTING OF BIOSAMPLE METRICS (sample collection, assay status, analyses updates). Provide study level updates to the study and global biomarker teams. Support study teams in addressing local vendor/site sample queries. Actively partner with Data Management to oversee and coordinate data format, and delivery timelines.

PROVIDE DAY TO DAY OPERATIONAL MANAGEMENT OF CHINA BIOSAMPLE VENDORS. Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions. Review central lab documents to ensure alignment with protocol and HGRAC submissions. Perform ongoing biomarker vendor management including development and oversight of scope of work, budget and performance management. Interact with vendors to help evaluate data size for compliance, plan sample shipments, export, storage, define data retention, ensure samples are analysed and data are transferred.

IDENTIFY AREAS OF BEST PRACTICE AND PROCESS IMPROVEMENTS. Contribute to the development of internal guidelines within Biosample Operations’ remit, based on HGRAC process and local regulations as well as program needs. Partner with relevant stakeholders, both locally and globally, to optimize processes for sample management in China.

DEMONSTRATE AGILITY AND ABILITY TO PERFORM IN A HIGHLY FAST-PACED, MATRIX ENVIRONMENT WHERE CROSS-TEAM COLLABORATION IS CRUCIAL. Leverage excellent verbal and written communication skills to motivate teams, negotiate with peers and partners and influence across stakeholders.

WHO YOU ARE

You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit.

Have a growth mindset and are excited about learning through experience

Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments

Have a 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Hold a Life Sciences degree in Scientific, Medical or Healthcare subject area. Further qualification, e.g. PhD and/or project management certification is desirable

Bring extensive clinical development experience with evidence of working in teams running clinical studies

Have a clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples

Have proven leadership skills, ability to successfully achieve results within a global, multi-cultural and geographically diverse team

Have (preferably) vendor management experience

Want to make a difference and find excitement in innovating practices, products and simplifying processes

Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines, HGRAC regulations

Are fluent in English (written and spoken)

At Roche/Genentech, we believe our people are Key to our success in bringing novel medicines to patients and we are fully dedicated to being a great place to work and to provide the services, tools and the environment where everybody feels empowered, trusted and is enabled to uncover his/her true potential. Come join us and help build a diverse and inclusive organization where patient centricity and patient access is a priority.

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。