Assistant Manager (Study Monitor)

Job Description

We are looking for an experienced clinical monitor to perform the study monitoring in ADVANcing Clinical Evidence in Infectious Diseases Network (ADVANCE ID). ADVANCE ID is jointly funded by the Wellcome Trust and Singapore institutions including the Saw Swee Hock School of Public Health and Yong Loo Lin School of Medicine, National University of Singapore.

The monitor should be able to supervise study sites and activities to ensure adherence to appropriate study protocols and applicable regulatory requirementterms of the study.

Qualifications

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit reports.

• Monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.

• Evaluate the quality and integrity of the reported data, site efficacy and investigational product (IP) management.

• Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.

• Develop patient recruitment strategies in conjunction with the clinical site to meet enrolment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).

• Assure that adverse events are correctly documented and reported.

•Ensure proper transmission of clinical case data to the data management centers,review case reports questions and problems and clarify or obtain alterations to data asappropriate.