Job Description

The Clinical Study Manager is responsible for the operation execution of assigned studies in China and APAC region. This role will be responsible for all study management aspects of a clinical study including but not limited to all the tasks specified in this .

The incumbent is to ensure that the assigned studies run to time, budget, and are completed in compliance with all relevant laws, regulations, ICH GCP, regulatory guidelines, as well as HOYA\xe2\x80\x99s policies and procedures.

Key Duties and Responsibilities

• Support all study activities at the study concept, planning phase including feasibility assessment, allocation of patients, investigator site selection, resources, development of essential documents and timelines
• Support and establish all clinical trial legal/financial documents (e.g., contracts, budgets, confidentiality agreement etc.)
• Oversee all activities at the study initiation phase which include all trial related documents development and review (e.g., study protocols, informed consent form, case report forms, advertising materials, presentation materials for investigator meetings, TMF, ISF etc.), development of enrolment initiatives/plans, plan study supplies, collect all documents from site and ensure all sites are trained in collaboration with the site monitor
• Develop all study documents for submission to the Ethics committee and regulator bodies
• Oversee all activities at the study management and conduct phase which include but not limited to day-to-day study management to ensure compliance, data quality and adherence to timeline, site quality activities, vendor/CRO management for outsource study, IP management, study enrolment tracking, TMF management, ongoing review of study data and data cleaning process
• Responsible for the conduct of co-monitoring activities with internal and external monitors to ensure compliance with GCP and protocol
• Support and ensure all close out activities are completed which include data base lock activities, completeness of TMF, and all study documents are properly archived
• Develop and maintain relationships with Key Opinion Leaders (KOL) and study staff to support Hoya\xe2\x80\x99s clinical activities
• Support the preparation and conduct of internal and external audits and Competent authority inspection with China/ APAC
• Other roles may be allotted as appropriate to the incumbent as required to delivery of the clinical studies

Education

• Professional education or bachelor\xe2\x80\x99s degree in a medical or scientific field; preferably optics.

Experience

• Preferably at least 2 years of experience in clinical study management in medical device industry, preferably in ophthalmology. 4-5 years in Monitoring operations

Skills

• Excellent interpersonal and written communication skills; pragmatic in problem solving; compliance mindset; systematic and disciplined
• Proficient at database systems, and Microsoft Office
• Competent in application of standard operating procedures, ICH GCP, Global regulations, Ethics, and compliance
• Experience in all phases of study execution
• Speak and write fluently in English and Chinese and work within international environment. Chinese is required for this role as this role is required to heavily support activities in China, which will include liaising with Chinese speaking vendors, regulators, patients, KOLs, etc.
• Strong organizational, interpersonal, written / verbal / influencing skills, with a strong attention to details
• Able to contribute to the overall morale of a team
• High emotional intelligence, relationship building and conflict management
• Good decision-making skills and task delegation
• Personal accountability

Travel Requirements

• Approximately 50%, mainly to China, and other APAC countries

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We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.