Maintaining and monitoring project plans, project schedules, budgets and expenditures, and confidentiality agreements.Ensuring projects adhere to frameworks and all documentation is maintained appropriately for each project.Preparing necessary presentation materials for meetings and providing administrative support as needed.Facilitate meetings where appropriate and distribute minutes to all project team members.Documenting and following up on important actions and decisions from meetings.Coordinate and host study monitor visits.Maintain a good understanding of regulatory guidelines (TPD, FDA, EMA, MHRA, ICH, TGA, ANVISA, NMPA) and understanding of basic pharmacokinetics and statistics.Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes proposals and contract templates, weekly tracking reports, financial reports etc.)Assist finance department in developing transfer of pertinent financial information.Administrative functions, as required by the position, will include, but will not be limited to data entry, filing, department mangement support, and assisting with company related activities as directed by the Executive Director/Director of Project Management.

• Management of patient appointments and health provider schedules using Appointment plus• Assist the nurse to fill in the required test requisition forms on-site and educate clients about the Rapid Antigen testing clinics and obtain consent.• Assist daily administrative operations of the clinic and report to the supervisor. • Ensure to collect and record accurate information of the client and update it in the shared folder appropriately in a timely manner. • Work across the team collaboratively to make sure the client's needs are met.

• Received, triaged, reviewed, and processed the adverse events and relevant corresponding case information into the Lifecycle Safety database from various sources documents on time and met quality standards.• Performed accurate coding of incoming adverse events and other case information using MedDRA dictionary.• Created comprehensive and precise case narratives based on relevant and related information from local affiliates and source documents, including spontaneous and solicited reports. • Checked mailbox, detected signals, and requested additional follow-up information from the affiliated site to complete the case reports and submit the regulatory reports within respective deadlines.

• Received, triaged, reviewed, and processed the adverse events and all relevant corresponding case information into the Lifecycle Safety database from various sources documents on time and met quality standards.• Performed accurate coding of incoming adverse events and other case information using MedDRA dictionary.• Created comprehensive and precise case narratives based on relevant and related information received from local affiliates and source documents, including spontaneous and solicited reports. • Checked mailbox, detected signals, and requested additional follow-up information from the affiliated site to complete the case reports and submit the regulatory reports within respective deadlines.

• Screened patients and healthy volunteers according to the agreed protocols, regulatory requirements, and sponsor SOPs. • Involved in reviewing study protocols and conduct a feasibility assessment to evaluate the progress of the study. • Participated in the development of standard operating procedures (SOPs) for trial-related activities.• Accurately and efficiently validate electronically captured data and writing queries on missing data and data points failing to meet the SOP requirements. • Liaised with the investigator, site personnel daily to request, receive, and correct documents and advise the site on completing pertinent investigator documents and IRB submissions.• Maintained and organized the study-related records, including the regulatory binders and participants' papers, to ensure the study documents were ready for audit