Clinical Study Manager APAC

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually. At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability. HSO way of working In fulfilling our roles, we are

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

About the role Job Title: Clinical Study Manager APAC Works closely with and have impact on: Global Clinical Affairs Team Reports to: Director, Clinical Affairs APAC Function: Global Clinical and Medical Affairs Role Overview 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 Job Description. 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’s policies and procedures. The incumbent must be able to work independently with minimal supervision. 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 regulatory 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’s 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

Requirements 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.
• Experience in the management of global studies
• Competent in application of standard operating procedures, ICH GCP, Global regulations, Ethics, and compliance
• Experience in all phases of study execution
• Experience in the conduct of device or ophthalmic studies

Skills/Accreditations

• Excellent interpersonal and written communication skills; pragmatic in problem solving; compliance mindset; systematic and disciplined
• Proficient at database systems, and Microsoft Office
• Speak and write fluently in English and Chinese and work within international environment. Chinese is required as this role is required to 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
• Ability to travel and work independently.
• Personal accountability

Academic Qualifications

• Professional education or bachelor’s degree in a medical or scientific field; preferably optics.

Approximately 50% By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy, which can be found here . We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding. #J-18808-Ljbffr