Key Responsibilities:

1. Maintain and facilitate interactions with internal functions including but not limited to Medical, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs, partners and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.

2. Accountable for all activities of site related study (including feasibility) execution of assigned studies / Monitors involving start-up, execution, and close-out.

3. Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.

4. Ensure adherence to applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Legend Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.

5. Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.

6. Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with Legend research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.

7. Responsible for the acquisition and retention, performance management, and growth and development of talent. May be responsible for being the point of contact for CROs for an assigned study / studies. May participate/lead in task forces and initiatives.

8. Responsible for identifying training needs and standardizing and facilitating training solutions for monitors. Provide consistent best practice approach to onboarding, consolidating "lessons learned" across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.

9. Assist in the creation of Standard Operating Procedures.

10. Additional responsibilities as required.

Qualifications:

1. Master degree in medicine, pharmacy or bio-technology.

2. At least 3 years clinical site management experience in pharmaceutical industry/CRO.

3. At least 1 year clinical project management experience is preferred.

4. Thorough knowledge on clinical trial regulatory requirements.

5. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.

6. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.

7. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience leading projects with competing deadlines.

8. Drives continuous improvement and simplicity in process and approach and enhances agility.

9. Demonstrated business ethics and integrity.

10. Language: Chinese & Business English fluency.

上班地址：上海市

金斯瑞生物科技 (GenScript Biotech Corp.) 是全球生物试剂定制化服务领域的领导者，经过多年的高速发展，目前业务已经拓展到精准免疫治疗、生物药定制开发（CDMO）、生物试剂产品和仪器，以及合成生物学在工业微生物的应用领域。公司在免疫治疗领域已经累积了丰富的研发管线，其创新的多发性骨髓瘤CAR-T制剂（南京传奇LCAR-B38M）在中美两国均取得了监管机构的临床试验许可。同时公司也已建成了开放式的技术驱动型生物药研发服务平台，符合GMP标准的质粒制备实验室，以及从酶系筛选、基因工程及蛋白质工程改造、发酵工艺优化、应用研究的完整工业微生物研发与产业化平台。在为更多的客户提供服务的同时，我们一直致力于利用生物科技让人类和自然更健康。

金斯瑞成立于2002年，现已跻身于全球化的跨国公司之列。公司总部位于中国南京，目前在南京和美国新泽西州设有研发、生产和运营中心，在镇江和济南有生产基地，并在欧洲设立了传奇爱尔兰和荷兰基地，在日本亦有全资子公司。公司利用在酶工程领域积累的技术和研发优势，在上海新建了生物催化研究院。这一系列资源，是金斯瑞集团为全球100多个国家与地区的20余万客户提供优质和便捷服务的坚实基础。

公司成立以来，始终秉持人才和科技是公司发展的源动力的观念 (Human Engine and Science Engine)，业务取得了飞速发展。目前公司2600多名员工中，有超过800人拥有硕士和博士以上的学位，在研发和商务团队中这个比例更是占90%以上。公司业务领域涵盖基因合成、寡核苷酸合成、蛋白生产、多肽合成、抗体开发、临床前药物研发、免疫精准治疗等广泛的生命科学研究及应用服务领域，生物试剂产品和仪器等目录产品业务，以及工业酶制剂和微生物制剂等工业应用领域。多年来凭借卓越的服务与产品质量以及良好的口碑，屹立于行业领先地位。在合成生物学、免疫治疗、抗体设计、化学合成和生物信息等领域有多项专利及商业技术机密，吸引了包括凯鹏华盈、堡航集团、华润集团及贝祥投资集团等多家著名投资机构的投资。