Duties and Responsibilities:
- Support all study activities during the concept and planning phases, including feasibility assessments, patient allocation, investigator site selection, resource planning, and the development of essential documents and timelines.
- Assist in the establishment and management of all clinical trial legal and financial documents, such as contracts, budgets, and confidentiality agreements.
- Oversee the study initiation phase, including the development and review of trial-related documents (e.g., study protocols, informed consent forms, case report forms, advertising materials, presentation materials for investigator meetings, TMF, ISF, etc.), the planning of enrolment initiatives, study supplies, and ensuring that all sites are trained in collaboration with the site monitor.
- Prepare and submit all necessary study documents to ethics committees and regulatory bodies.
- Manage the study conduct phase by overseeing day-to-day study management to ensure compliance, data quality, adherence to timelines, site quality activities, vendor/CRO management for outsourced studies, IP management, study enrolment tracking, TMF management, and ongoing review and cleaning of study data.
- Conduct co-monitoring activities with internal and external monitors to ensure compliance with GCP and study protocols.
- Ensure all study closeout activities are completed, including database lock activities, TMF completeness, and proper archiving of all study documents.
- Develop and maintain relationships with Key Opinion Leaders (KOL) and study staff to support clinical activities.
- Assist in the preparation and conduct of internal and external audits and inspections by competent authorities in China/APAC.
- Perform additional roles as required to ensure the successful delivery of clinical studies.
Requirements:
- Preferably at least 2 years of experience in clinical study management within the medical device industry, ideally in ophthalmology, with 4-5 years in monitoring operations.
- Experience in managing global studies.
- Proficient in applying standard operating procedures, ICH GCP, global regulations, ethics, and compliance.
- Experience across all phases of study execution.
- Familiarity with conducting device or ophthalmic studies.
- Require to travel overseas if required
All qualified applicants, please send in your resume to:
Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599
