Clinical Trial Manager

This position is responsible for independently leading and overseeing assigned clinical trial in Japan, from study start-up through execution and completion of all deliverables. The role involves managing SSU/CRA activities and site interactions through a Functional Service Provider (FSP), while closely collaborating with headquarters Clinical Project Managers (CPMs). In addition, the position is expected to work closely with internal stakeholders, including the Japan Clinical Science Liaison (CSL) team, to ensure that clinical trials are conducted as planned and to a high standard of quality.

Key Responsibilities

Review and/or develop project management plans; define KPIs; provide progress reports; and resolve issues as they ariseManage study timelines (including the critical path), consider approaches to shorten timelines, and proactively identify and address delays and risksMonitor and manage key performance indicators (KPIs) across all investigational sites in JapanCommunicate with global CPMs in English, including requests for confirmation and reporting of study progressManage study sites through FSP-provided CRAsOversee and support CRA activitiesEnsure compliance of SSU/CRA activities with standard operating procedures (SOPs) and applicable regulatory requirementsReview and approve monitoring visit reportsOversee EDC query management in collaboration with CRAs and data management teamsOversee eTMF management and ensure document qualityManage site-related costs and budgetsPlan and facilitate Japan Clinical Operations team meetingsProvide realistic, Japan‑specific perspectives and recommendations on trial operational strategies, and align with the HQ CPMs through effective communication and consensus building.Requirement:This position requires hands-on study management experience with the ability to independently drive clinical trials in Japan, as well as the capability to work effectively in a global environment.Required Experience and Skills:At least 7 years of clinical development experience in the pharmaceutical industry or at a Contract Research Organization (CRO)Site-level study management experience as a CTM / PMExperience overseeing and managing FSP-provided CRAsClinical trial experience in the oncology fieldExperience with day-to-day operational communication with global study teamsExperience managing cross‑functional teamsPractical experience participating in meetings conducted in English and providing study progress updates in EnglishCapabilities and Language Requirements:In addition to fundamental English communication skills for daily business, this position requires strong coordination skills and flexibility when collaborating with global teams, particularly with headquarters in China.The role requires the ability to communicate effectively with internal and external stakeholders, respond appropriately to changes in direction, support timely decision-making, and build strong, trust-based relationships across functions and organizations.About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.For more information, please visit https://www.henlius.com/en/Index.html