Arwen C.

Work both independently and as part of a team when required, and cooperate & communicate with different departments and different stakeholders from outside. Responsible for EC/AC submission, contract negotiation, and on-site monitoring, including SIV, MV, & COV, etc., Import/ Export license applications, or as a CPM to conduct the project management and cooperate with the assigned CRO. Trained by the global CRO/Sponsor as a team member and reported to the team or sponsors directly, and maintained a close relationship with KOLs & the site members for the projects. Discuss with PI & the sites for making the specific recruitment strategies for the sites in APAC, including Taiwan, China, & Singapore.

Responded to project management and control of the process on time as a project lead; evaluated and arranged the study budgets & determined payment plans and schedules. Effectively communicated with different inner departments, stakeholders, and site staff for protocol design/ project development. Coordinated with DM and discussed with KOLs as a PM for CRF & EDC contents and improvements. Trained & coached 4 junior CRAs in conducting on-site monitoring to ensure compliance with protocols and local regulations.

Responded to project management and control of the process on time as a project lead. Conducted EC submissions, budget negotiations, CTA preparations, on-site monitoring, and IRB audits. Coordinated with DM and discussed with KOLs for the development of protocols, CRF, ICF, and data-related materials. Effectively communicated with different inner departments, stakeholders, and site staff for protocol design/project development.

Responded to project management and control of the process on time as a PM; cooperated with CRO for on-site monitoring, confirming each detail complied with the protocols. Conducted submission, budget negotiation, and CTA preparations with the site members and the internal law department following the site requests & local regulations. Created, developed, and maintained TMF in both paper and electronic systems. Coordinated with DM and discussed with KOLs for the development of protocols, CRF, ICF, and data-related materials.

Responded to planning and executing the local conferences & the inner training courses; attended the global annual meetings to acquire professional information & accumulated the conference experiences. Executed overall brand marketing programs according to the global strategies. Engaged and maintained a good relationship with the sales team, KOLs, and stakeholders. Conducted the local late-phase studies for marketing research and competitor comparison.

Conducted animal research to investigate and identify the drug efficiency. Prepared and completed the FDA reports for the patent application. Responded to laboratory management, including conducting the training courses, managing the data documentation, and other related affairs with stakeholders as the lab representative. Established and developed several protocols for cell mechanism investigation.