• Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents.

• Assist in coordination of clinical studies from site selection through site activation. That involves but not limited to

▪ Conduct SQV in selected sites;

▪ Take EC application and get EC approval from confirmed sites;

▪ Negotiate, finalize and get final signing of the clinical study agreement and related amendments from confirmed sites;

▪ Assist to get HGR application required documents from confirmed sites.

▪ Assist local study team to prepare site initiation visit in site.

• Actively participate in local Study Delivery Team meetings and work cross functionally with Clinical Trial Support Team in China SM&M.

• Activate study sites in compliance with Procedural Documents.

• Share information (metrics) on study site progress towards activation within local Study Delivery Team and China SM&M leadership as required.

• Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.

• Update IMPACT and other systems with data from centres as per required per Site Optimization Team (SOT) process.

• Ensure regulatory binders are provided for study site start up and/or delivered as per SOT process and agreement with Local Study Delivery Team.

• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.• Ensure compliance with company’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).

• Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.

• Contribute to the production of study start up documents, ensuring template and version compliance.

• Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in ANGEL.• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems.

• Regular communication with key/mega site and influence the trial delivery in hospital level.

Additional Responsibilities May Include

• Contribute to process improvements, knowledge transfer and best practice sharing.

• Actively share applicable information that may be relevant to other functions.

• University degree in related discipline, preferably in life science, or equivalent qualification.

• Fluent knowledge of spoken and written English.

• More than 2 years working experience. Previous experience as CRA is a must, previous experience as SSU is a plus and current SCRA is a big plus!

• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Basic understanding of the drug development process.

• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

• Ability to travel nationally as required.