Responsibilities:

To take on the general clinical support role according to SOP and GCP/ICH guidelines and other regulatory requirements. Key focus is on providing clinical study related support to the study teams.

1) Preparing meeting logistics, distributing agendas, and minutes for study team meeting, and meetings with CRO, Investigator Meetings, Workshop, Inspection, etc.

2) Manage study related purchase and payment, incl. sourcing, contract with vendors in service of translations, meetings, GCP QC etc.

3) Compile and maintain vendor profile.

4) Track and maintain spreadsheets to track vendor contracts.

5) Support CSA (Clinical Study Agreement) and Amendment signature and stamp, as well as track and archiving.

6) Take the role as assigned insurance person in DSCN, work with the insurance company to obtain study specific insurance. Maintain good relationship and oversight the insurance company deemed appropriate.

7) Support study manager on compensation, including work with CRO/CRC/site to collect claims materials, assist to execute settlement agreement and payment.

8) Compile and maintain spreadsheets track insurance procuring and compensation.

9) Work with supervisor to provide input into insurance related process and SOP.

10) Make recommendations for the areas of improvement and innovation (study, or department level).

Qualification:

• Bachelor’s degree in management, Pharmacy, Biomedical, Life Science, Public health, Chemistry, and biological science related. Advanced degree preferred.

• At least 2 years or above in the multinational clinical department in pharmaceutical industry.

• Experience considered relevant includes clinical or basic research in a pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO).

• Demonstrates knowledge of complex processes related to clinical studies, regulatory issues, CRO operations, and compliance practices.

• Good interpersonal skills and ability to work in an international team environment.

• Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members).

• Effectively manages information, data, related analyses, forms and reports.

• Identifies and resolves problems when able to.

• Willingness and ability to train others on study administration procedures.

• Display excellent organization and time management skills, excellent attention to detail, and supports and effectively multi-task different and complex assignments and responsibilities in a high-volume environment with shifting priorities.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

• Integrity and high ethical standards

• Good knowledge of spoken and written English.

• Computer proficiency of Word/Excel/PowerPoint.