HGR Management

该职位来源于猎聘

• Services rendered will adhere to applicable SOPs, policies, local regulatory requirements, ICH-GCP, etc.
• Drive Human Genetic Resource (HGR) application and progress tracking for In-house studies across Therapeutical Area.
• Proactively work with local study teams to prepare HGR (on-line) submission, responsible for the HGR on-line data entry and submission, as well as responsible for the HGR approval application dossier collection and preparation.
• Maintain HGR application, approval and samples exportation related data tracking, as well as the relevant files archiving.
• With support from Operations Compliance Rep/equivalent role and local compliance, as well as manager from Sponsor, etc., proactively work with local study teams to monitor HGR implementation compliance, address issues and concerns in response to the changes from internal/external environmental factors , proactively resolve HGR related sample issues.
• Ensure HGR approval, sample exportation approval, and CIQ approval, in line with Health Authority-related regulations and requirements.
• Contribute to Self-Inspection/Inspection preparation and completion, if needed.
• Provide support to HGR-related activities of outsourced studies per business needs and requirements.
• Contribute to the HGR management to across Therapeutical Areas clinical trials, including but not limited: Sponsor-self inspection/on-site inspection and system audit.
• Contribute to process optimization of HGR-related activities with Cross Functions and Functional Managers support
• A minimum of a BA/BS degree is preferred.
• Skills set corresponding with preferentially 2+ years’ relevant clinical trial experience or equivalent. Advance level should have 4+ years' relevant experience.
• Certain working knowledge of ICH-GCP company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures, etc.,
• Good English capabilities, including good oral and written spoken English skills.
• Good communications skills.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer, and PowerPoint).
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.